Other products from "INFRAREDX, INC."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00857595006005 TVC-MC8-B1 TVC-MC8-B1 Individual Sterile Barrier for TVC-MC8 or TVC-MC9 System Controller IYO,OGZ System, Imaging, Pulsed Echo, Ultrasonic,Catheter, Intravascular, Plaque Morphol System, Imaging, Pulsed Echo, Ultrasonic,Catheter, Intravascular, Plaque Morphology Evaluation TVC Controller Sterile Barrier
2 00857595006425 TVC-MC9 TVC-MC9 TVC Imaging System™The TVC Imaging System™ (TVC-MC9) is a dual-modality intravas TVC Imaging System™The TVC Imaging System™ (TVC-MC9) is a dual-modality intravascular imaging system that enables structural and chemical assessment of coronary arteries and plaques by using integrated NIRS (near infrared spectroscopy) and Extended Bandwidth™ IVUS imaging technology to identify lipid-core plaques (LCP) of interest. The system utilizes proprietary NIRS analysis and 50MHz Extended Bandwidth rotational IVUS imaging from a single catheter. The system features a touch screen control interface and a workflow that fits the complex catheterization laboratory environment. The system is compatible with the TVC Insight XB™ Extended Bandwidth NIRS-IVUS Catheter Kit (TVC-C195-32).Indications for Use:1. The TVC Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures. IYO,OGZ System, Imaging, Pulsed Echo, Ultrasonic,Catheter, Intravascular, Plaque Morphol System, Imaging, Pulsed Echo, Ultrasonic,Catheter, Intravascular, Plaque Morphology Evaluation 2 TVC Imaging System™
3 00857595006418 TVC-MC8 TVC-MC8 TVC Imaging System™The TVC Imaging System™ (TVC-MC8) is a dual-modality intravas TVC Imaging System™The TVC Imaging System™ (TVC-MC8) is a dual-modality intravascular imaging system that enables structural and chemical assessment of coronary arteries and plaques by using integrated NIRS (near infrared spectroscopy) and enhanced IVUS imaging technology to identify lipid-core plaques (LCP) of interest. The system utilizes proprietary NIRS analysis and 40MHz rotational IVUS imaging from a single catheter. The system is compatible with the TVC Insight™ Catheter Kit (TVC-C195-20) and TVC Insight Hydrophilic Catheter Kit (TVC-C195-22). The system can be configured for Extended Bandwidth™ making the system compatible with the TVC Insight XB™ Extended Bandwidth NIRS-IVUS Catheter Kit (TVC-C195-32) that provides NIRS and 50MHz rotational IVUS imaging.Indications for Use:1. The TVC Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures. OBJ,OGZ Catheter, Ultrasound, Intravascular,Catheter, Intravascular, Plaque Morphology Evaluation 2 TVC Imaging System™
4 00857595006401 TVC-MC8 TVC-MC8 TVC Imaging System™The TVC Imaging System™ (TVC-MC8) is a dual-modality intravas TVC Imaging System™The TVC Imaging System™ (TVC-MC8) is a dual-modality intravascular imaging system that enables structural and chemical assessment of coronary arteries and plaques by using integrated NIRS (near infrared spectroscopy) and enhanced IVUS imaging technology to identify lipid-core plaques (LCP) of interest. The system utilizes proprietary NIRS analysis and 40MHz rotational IVUS imaging from a single catheter. The system is compatible with the TVC Insight™ Catheter Kit (TVC-C195-20) and TVC Insight Hydrophilic Catheter Kit (TVC-C195-22). The system can be configured for Extended Bandwidth™ making the system compatible with the TVC Insight XB™ Extended Bandwidth NIRS-IVUS Catheter Kit (TVC-C195-32) that provides NIRS and 50MHz rotational IVUS imaging. Non-RoHsIndications for Use:1. The TVC Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures. OBJ,OGZ Catheter, Ultrasound, Intravascular,Catheter, Intravascular, Plaque Morphology Evaluation 2 TVC Imaging System™
5 00857595006234 TVC-C195-42 TVC-C195-42 The Dualpro™ IVUS+NIRS Imaging Catheter Kit (TVC-C195-42) is a single use, dispo The Dualpro™ IVUS+NIRS Imaging Catheter Kit (TVC-C195-42) is a single use, disposable coronary catheter and accessory kit designed for use only with the Makoto Intravascular Imaging System™ (TVC-MC10 and TVC-MC10i). The dual-modality intravascular imaging catheter combines 50 MHz Extended Bandwidth IVUS transducer and laser-based near infrared spectroscopy (NIRS) for simultaneous acquisition of vessel structure and plaque composition data— a single catheter, a single pullback, two sets of data. The Dualpro™ IVUS+NIRS Imaging Catheter features a durable hydrophilic coating for improved deliverability.Indications for Use:1. The Makoto Intravascular Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures. IYO,OGZ System, Imaging, Pulsed Echo, Ultrasonic,Catheter, Intravascular, Plaque Morphol System, Imaging, Pulsed Echo, Ultrasonic,Catheter, Intravascular, Plaque Morphology Evaluation 2 Dualpro™ IVUS+NIRS Imaging Catheter Kit
6 04543660023515 GLGMF-YOK0A This angioplasty convenience kit contains one(1) sterile pouch with OKAY-II with This angioplasty convenience kit contains one(1) sterile pouch with OKAY-II with kit and one(1) sterile pouch with a GM-30 Inflation Device.The OKAY® II Y-Connector Set reduces blood loss during procedures through the use of a hemostatic valve not featured on conventional Y-connectors. Its large 3.33mm (10F) inner diameter facilitates a variety of PCI devices and techniques, and a new feature has been added that allows the one-touch style hemostatic valve to be locked in the open position. Includes Y-connector, torque device, and introducer. (YOK0A)The GM-30 30atm-25cc inflation device features standard length, 31 cm, high pressure tubing and 4 position stopcock for single or dual angioplasty balloon inflation and deflation. (GM-30NF)Indications for Use:1. The Y-connector is designed to work in conjunction with guiding catheters, etc. to reduce blood loss while assisting in manipulation of catheters, etc., injection of contrast solution from a side port, injection of medicine or saline solution, and measurement of blood pressure.2. The inflation device is recommended for use with balloon dilation catheters to create and monitor pressure in the balloon, and to deflate the balloon. PTM,DTL Syringe, Balloon Inflation, Exempt,Adaptor, Stopcock, Manifold, Fitting, Cardiop Syringe, Balloon Inflation, Exempt,Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass 2 GM-30 Accessory Kit
7 04543660023508 GLGMN-YOK0A This angioplasty convenience kit contains one(1) sterile pouch with OKAY-II with This angioplasty convenience kit contains one(1) sterile pouch with OKAY-II with kit and one(1) sterile pouch with a GM-30 Inflation Device.OKAY® II Y-Connector Set with Extension Tube reduces blood loss during procedures through the use of a hemostatic valve not featured on conventional Y connectors. Its large 3.33mm (10F) inner diameter facilitates a variety of PCI devices and techniques, and a new feature has been added that allows the one-touch style hemostatic valve to be locked in the open position. Includes Y-connector, torque device, and introducer. (YOK0A)The GM-30 30atm-25cc inflation device features standard length, 31 cm, high pressure tubing and 3 position stopcock for single angioplasty balloon inflation and deflation. (GM-30N)Indications for Use:1. The Y-connector is designed to work in conjunction with guiding catheters, etc. to reduce blood loss while assisting in manipulation of catheters, etc., injection of contrast solution from a side port, injection of medicine or saline solution, and measurement of blood pressure.2. The inflation device is recommended for use with balloon dilation catheters to create and monitor pressure in the balloon, and to deflate the balloon. PTM,DTL Syringe, Balloon Inflation, Exempt,Adaptor, Stopcock, Manifold, Fitting, Cardiop Syringe, Balloon Inflation, Exempt,Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass 2 GM-30 Accessory Kit
8 04543660023492 GLGMF-YOK0E This angioplasty convenience kit contains one(1) sterile pouch with OKAY-II with This angioplasty convenience kit contains one(1) sterile pouch with OKAY-II with kit and extension tube and one(1) sterile pouch with a GM-30 Inflation Device.OKAY® II Y-Connector Set with Extension Tube reduces blood loss during procedures through the use of a hemostatic valve not featured on conventional Y connectors. Its large 3.33mm (10F) inner diameter facilitates a variety of PCI devices and techniques, and a new feature has been added that allows the one-touch style hemostatic valve to be locked in the open position. Includes Y-connector, torque device, introducer, and extension tube. (YOK0E)The GM-30 30atm-25cc inflation device features standard length, 31 cm, high pressure tubing and 4 position stopcock for single or dual angioplasty balloon inflation and deflation. (GM-30NF)Indications for Use:1. The Y-connector is designed to work in conjunction with guiding catheters, etc. to reduce blood loss while assisting in manipulation of catheters, etc., injection of contrast solution from a side port, injection of medicine or saline solution, and measurement of blood pressure.2. The inflation device is recommended for use with balloon dilation catheters to create and monitor pressure in the balloon, and to deflate the balloon. PTM,DTL Syringe, Balloon Inflation, Exempt,Adaptor, Stopcock, Manifold, Fitting, Cardiop Syringe, Balloon Inflation, Exempt,Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass 2 GM-30 Accessory Kit
9 04543660023485 GLGMN-YOK0E This angioplasty convenience kit contains one(1) sterile pouch with OKAY-II with This angioplasty convenience kit contains one(1) sterile pouch with OKAY-II with kit and extension tube and one(1) sterile pouch with a GM-30 Inflation Device.OKAY® II Y-Connector Set with Extension Tube reduces blood loss during procedures through the use of a hemostatic valve not featured on conventional Y connectors. Its large 3.33mm (10F) inner diameter facilitates a variety of PCI devices and techniques, and a new feature has been added that allows the one-touch style hemostatic valve to be locked in the open position. Includes Y-connector, torque device, introducer, and extension tube. (YOK0E)The GM-30 30atm-25cc inflation device features standard length, 31 cm, high pressure tubing and 3 position stopcock for single angioplasty balloon inflation and deflation. (GM-30N)Indications for Use:1. The Y-connector is designed to work in conjunction with guiding catheters, etc. to reduce blood loss while assisting in manipulation of catheters, etc., injection of contrast solution from a side port, injection of medicine or saline solution, and measurement of blood pressure.2. The inflation device is recommended for use with balloon dilation catheters to create and monitor pressure in the balloon, and to deflate the balloon. PTM,DTL Syringe, Balloon Inflation, Exempt,Adaptor, Stopcock, Manifold, Fitting, Cardiop Syringe, Balloon Inflation, Exempt,Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass 2 GM-30 Accessory Kit
10 04543660022341 YOK0B OKAY II reduces blood loss during procedures through the use of a hemostatic val OKAY II reduces blood loss during procedures through the use of a hemostatic valve not featured on conventional Y connectors. Its large 3.33mm (10F) inner diameter facilitates a variety of PCI devices and techniques, and a new feature has been added that allows the one-touch style hemostatic valve to be locked in the open position. Includes Y-connector.Indications for Use:1. This product is designed to work in conjunction with guiding catheters, etc. to reduce blood loss while assisting in manipulation of catheters, etc., injection of contrast solution from a side port, injection of medicine or saline solution, and measurement of blood pressure. DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass OKAY® II Y-Connector
11 00857595006203 TVC-C195-20 TVC-C195-20 Insight Catheter™ Kit The TVC Insight Catheter™ Kit (TVC-C195-20) is a single us Insight Catheter™ Kit The TVC Insight Catheter™ Kit (TVC-C195-20) is a single use, disposable coronary catheter and accessory kit designed for use only with the TVC Imaging System™ (TVC-MC8). The dual-modality intravascular imaging catheter combines laser-based near infrared spectroscopy (NIRS) and high fidelity 40 MHz ultrasonics for simultaneous acquisition of vessel structure and plaque composition—a single catheter, a single pullback, two sets of data. The catheter features a 40MHz wide bandwidth IVUS transducer.Indications for Use: 1. The TVC Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures. IYO,OBJ,OGZ System, Imaging, Pulsed Echo, Ultrasonic,Catheter, Ultrasound, Intravascular,Cat System, Imaging, Pulsed Echo, Ultrasonic,Catheter, Ultrasound, Intravascular,Catheter, Intravascular, Plaque Morphology Evaluation TVC Insight™
12 04543660022662 GM-30NL GM-30NL 30atm-25cc Inflation Device. Features extended length, 76 cm, high pressure tubi 30atm-25cc Inflation Device. Features extended length, 76 cm, high pressure tubing and 3 position stopcock for balloon inflation and deflation.Indications for Use:1. This device is recommended for use with balloon dilation catheters to create and monitor pressure in the balloon, and to deflate the balloon. PTM Syringe, Balloon Inflation, Exempt 2 GM-30 Inflation Device
13 04543660022655 GM-30NF GM-30NF 30atm-25cc Inflation Device. Features standard length, 31 cm, high pressure tubi 30atm-25cc Inflation Device. Features standard length, 31 cm, high pressure tubing and 4 position stopcock for single or dual angioplasty balloon inflation and deflation.Indications for Use:1. This device is recommended for use with balloon dilation catheters to create and monitor pressure in the balloon, and to deflate the balloon. PTM Syringe, Balloon Inflation, Exempt 2 GM-30 Inflation Device
14 04543660022648 GM-30N GM-30N 30atm-25cc Inflation Device. Features standard length, 31 cm, high pressure tubi 30atm-25cc Inflation Device. Features standard length, 31 cm, high pressure tubing and 3 position stopcock for angioplasty balloon inflation and deflation.Indications for Use:1. This device is recommended for use with balloon dilation catheters to create and monitor pressure in the balloon, and to deflate the balloon. PTM Syringe, Balloon Inflation, Exempt 2 GM-30 Inflation Device
15 04543660022334 YOK0A OKAY II reduces blood loss during procedures through the use of a hemostatic val OKAY II reduces blood loss during procedures through the use of a hemostatic valve not featured on conventional Y connectors. Its large 3.33mm (10F) inner diameter facilitates a variety of PCI devices and techniques, and a new feature has been added that allows the one-touch style hemostatic valve to be locked in the open position. Includes Y-connector, torque device, and introducer.Indications for Use:1. This product is designed to work in conjunction with guiding catheters, etc. to reduce blood loss while assisting in manipulation of catheters, etc., injection of contrast solution from a side port, injection of medicine or saline solution, and measurement of blood pressure. DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass OKAY® II Y-Connector Set
16 04543660022358 YOK0E OKAY II reduces blood loss during procedures through the use of a hemostatic val OKAY II reduces blood loss during procedures through the use of a hemostatic valve not featured on conventional Y connectors. Its large 3.33mm (10F) inner diameter facilitates a variety of PCI devices and techniques, and a new feature has been added that allows the one-touch style hemostatic valve to be locked in the open position. Includes Y-connector, torque device, introducer, and extension tube.Indications for Use:1. This product is designed to work in conjunction with guiding catheters, etc. to reduce blood loss while assisting in manipulation of catheters, etc., injection of contrast solution from a side port, injection of medicine or saline solution, and measurement of blood pressure. DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass OKAY® II Y-Connector Set with Extension Tube
17 00857595006227 TVC-C195-32 TVC-C195-32 Insight XB™ Catheter KitThe TVC Insight XB™ Extended Bandwidth™ NIRS-IVUS Cathet Insight XB™ Catheter KitThe TVC Insight XB™ Extended Bandwidth™ NIRS-IVUS Catheter Kit (TVC-C195-32) is a single use, disposable coronary catheter and accessory kit designed for use only with the TVC Imaging System™(TVC-MC9, TVC-MC9i, and properly configured TVC-MC8). The dual-modality intravascular imaging catheter combines laser-based near infrared spectroscopy (NIRS) and 50 MHz Extended Bandwidth ultrasonics for simultaneous acquisition of vessel structure and plaque composition— a single catheter, a single pullback, two sets of data. The Insight XB catheter features a 50MHz Extended Bandwidth IVUS transducer and durable hydrophilic coating for improved delivery.Indications for Use:1. The TVC Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures. IYO,OGZ System, Imaging, Pulsed Echo, Ultrasonic,Catheter, Intravascular, Plaque Morphol System, Imaging, Pulsed Echo, Ultrasonic,Catheter, Intravascular, Plaque Morphology Evaluation TVC Insight XB™
18 00857595006623 TVC-MC9i TVC-MC9i TThe TVC Integrated Imaging System™ (TVC-MC9i) is a dual-modality intravascular TThe TVC Integrated Imaging System™ (TVC-MC9i) is a dual-modality intravascular imaging system that enables structural and chemical assessment of coronary arteries and plaques by using integrated NIRS (near infrared spectroscopy) and Extended Bandwidth™ IVUS imaging technology to identify lipid-core plaques (LCP) of interest. The system utilizes proprietary NIRS analysis and 50MHz Extended Bandwidth rotational IVUS imaging from a single catheter. This model of TVC Imaging System is designed to be installed in the catheterization laboratory and minimize usage of space. The system features a touch screen control interface and a workflow that fits the complex catheterization laboratory environment. The system is compatible with the TVC Insight XB™ Extended Bandwidth NIRS-IVUS Catheter Kit (TVC-C195-32). Indications for Use:1. The TVC Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures. IYO,OGZ System, Imaging, Pulsed Echo, Ultrasonic,Catheter, Intravascular, Plaque Morphol System, Imaging, Pulsed Echo, Ultrasonic,Catheter, Intravascular, Plaque Morphology Evaluation 2 TVC Integrated Imaging System™
19 00857595006432 TVC-MC10 TVC-MC10 The Makoto Intravascular Imaging System™ (TVC-MC10) is a dual-modality intravasc The Makoto Intravascular Imaging System™ (TVC-MC10) is a dual-modality intravascular imaging system that enables structural and chemical assessment of coronary arteries and plaques by using integrated Extended Bandwidth IVUS imaging and NIRS (near infrared spectroscopy) technologies to identify lipid-core plaques (LCP) of interest. The system utilizes proprietary NIRS analysis and 50 MHz Extended Bandwidth rotational IVUS imaging from a single catheter. The system features a touch screen control interface and a workflow that fits the complex catheterization laboratory environment. The system is compatible with the Dualpro™ IVUS+NIRS Imaging Catheter Kit (TVC-C195-42). Indications for Use:1. The Makoto Intravascular Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures. IYO,OGZ System, Imaging, Pulsed Echo, Ultrasonic,Catheter, Intravascular, Plaque Morphol System, Imaging, Pulsed Echo, Ultrasonic,Catheter, Intravascular, Plaque Morphology Evaluation 2 Makoto Intravascular Imaging System™
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33 00860005688111 FG10594 The NuVision Connector Cable is a non-sterile, reusable connector cable intended The NuVision Connector Cable is a non-sterile, reusable connector cable intended to connect the sterile, single-use NuVision ICE Catheter to a qualified GE ultrasound cardiac imaging system. NuVision Connector Cable NUVERA MEDICAL, INC.
34 00860005688104 FG10593 The NUVISION™ ICE Catheter is a diagnostic ultrasound imaging catheter designed The NUVISION™ ICE Catheter is a diagnostic ultrasound imaging catheter designed for intracardiac use. NuVision ICE Catheter NUVERA MEDICAL, INC.
35 00857595006623 TVC-MC9i TVC-MC9i TThe TVC Integrated Imaging System™ (TVC-MC9i) is a dual-modality intravascular TThe TVC Integrated Imaging System™ (TVC-MC9i) is a dual-modality intravascular imaging system that enables structural and chemical assessment of coronary arteries and plaques by using integrated NIRS (near infrared spectroscopy) and Extended Bandwidth™ IVUS imaging technology to identify lipid-core plaques (LCP) of interest. The system utilizes proprietary NIRS analysis and 50MHz Extended Bandwidth rotational IVUS imaging from a single catheter. This model of TVC Imaging System is designed to be installed in the catheterization laboratory and minimize usage of space. The system features a touch screen control interface and a workflow that fits the complex catheterization laboratory environment. The system is compatible with the TVC Insight XB™ Extended Bandwidth NIRS-IVUS Catheter Kit (TVC-C195-32). Indications for Use:1. The TVC Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures. TVC Integrated Imaging System™ INFRAREDX, INC.
36 00857595006432 TVC-MC10 TVC-MC10 The Makoto Intravascular Imaging System™ (TVC-MC10) is a dual-modality intravasc The Makoto Intravascular Imaging System™ (TVC-MC10) is a dual-modality intravascular imaging system that enables structural and chemical assessment of coronary arteries and plaques by using integrated Extended Bandwidth IVUS imaging and NIRS (near infrared spectroscopy) technologies to identify lipid-core plaques (LCP) of interest. The system utilizes proprietary NIRS analysis and 50 MHz Extended Bandwidth rotational IVUS imaging from a single catheter. The system features a touch screen control interface and a workflow that fits the complex catheterization laboratory environment. The system is compatible with the Dualpro™ IVUS+NIRS Imaging Catheter Kit (TVC-C195-42). Indications for Use:1. The Makoto Intravascular Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures. Makoto Intravascular Imaging System™ INFRAREDX, INC.
37 00857595006425 TVC-MC9 TVC-MC9 TVC Imaging System™The TVC Imaging System™ (TVC-MC9) is a dual-modality intravas TVC Imaging System™The TVC Imaging System™ (TVC-MC9) is a dual-modality intravascular imaging system that enables structural and chemical assessment of coronary arteries and plaques by using integrated NIRS (near infrared spectroscopy) and Extended Bandwidth™ IVUS imaging technology to identify lipid-core plaques (LCP) of interest. The system utilizes proprietary NIRS analysis and 50MHz Extended Bandwidth rotational IVUS imaging from a single catheter. The system features a touch screen control interface and a workflow that fits the complex catheterization laboratory environment. The system is compatible with the TVC Insight XB™ Extended Bandwidth NIRS-IVUS Catheter Kit (TVC-C195-32).Indications for Use:1. The TVC Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures. TVC Imaging System™ INFRAREDX, INC.
38 00857595006418 TVC-MC8 TVC-MC8 TVC Imaging System™The TVC Imaging System™ (TVC-MC8) is a dual-modality intravas TVC Imaging System™The TVC Imaging System™ (TVC-MC8) is a dual-modality intravascular imaging system that enables structural and chemical assessment of coronary arteries and plaques by using integrated NIRS (near infrared spectroscopy) and enhanced IVUS imaging technology to identify lipid-core plaques (LCP) of interest. The system utilizes proprietary NIRS analysis and 40MHz rotational IVUS imaging from a single catheter. The system is compatible with the TVC Insight™ Catheter Kit (TVC-C195-20) and TVC Insight Hydrophilic Catheter Kit (TVC-C195-22). The system can be configured for Extended Bandwidth™ making the system compatible with the TVC Insight XB™ Extended Bandwidth NIRS-IVUS Catheter Kit (TVC-C195-32) that provides NIRS and 50MHz rotational IVUS imaging.Indications for Use:1. The TVC Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures. TVC Imaging System™ INFRAREDX, INC.
39 00857595006418 TVC-MC8 TVC-MC8 TVC Imaging System™The TVC Imaging System™ (TVC-MC8) is a dual-modality intravas TVC Imaging System™The TVC Imaging System™ (TVC-MC8) is a dual-modality intravascular imaging system that enables structural and chemical assessment of coronary arteries and plaques by using integrated NIRS (near infrared spectroscopy) and enhanced IVUS imaging technology to identify lipid-core plaques (LCP) of interest. The system utilizes proprietary NIRS analysis and 40MHz rotational IVUS imaging from a single catheter. The system is compatible with the TVC Insight™ Catheter Kit (TVC-C195-20) and TVC Insight Hydrophilic Catheter Kit (TVC-C195-22). The system can be configured for Extended Bandwidth™ making the system compatible with the TVC Insight XB™ Extended Bandwidth NIRS-IVUS Catheter Kit (TVC-C195-32) that provides NIRS and 50MHz rotational IVUS imaging.Indications for Use:1. The TVC Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures. TVC Imaging System™ INFRAREDX, INC.
40 00857595006401 TVC-MC8 TVC-MC8 TVC Imaging System™The TVC Imaging System™ (TVC-MC8) is a dual-modality intravas TVC Imaging System™The TVC Imaging System™ (TVC-MC8) is a dual-modality intravascular imaging system that enables structural and chemical assessment of coronary arteries and plaques by using integrated NIRS (near infrared spectroscopy) and enhanced IVUS imaging technology to identify lipid-core plaques (LCP) of interest. The system utilizes proprietary NIRS analysis and 40MHz rotational IVUS imaging from a single catheter. The system is compatible with the TVC Insight™ Catheter Kit (TVC-C195-20) and TVC Insight Hydrophilic Catheter Kit (TVC-C195-22). The system can be configured for Extended Bandwidth™ making the system compatible with the TVC Insight XB™ Extended Bandwidth NIRS-IVUS Catheter Kit (TVC-C195-32) that provides NIRS and 50MHz rotational IVUS imaging. Non-RoHsIndications for Use:1. The TVC Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures. TVC Imaging System™ INFRAREDX, INC.
41 00857595006401 TVC-MC8 TVC-MC8 TVC Imaging System™The TVC Imaging System™ (TVC-MC8) is a dual-modality intravas TVC Imaging System™The TVC Imaging System™ (TVC-MC8) is a dual-modality intravascular imaging system that enables structural and chemical assessment of coronary arteries and plaques by using integrated NIRS (near infrared spectroscopy) and enhanced IVUS imaging technology to identify lipid-core plaques (LCP) of interest. The system utilizes proprietary NIRS analysis and 40MHz rotational IVUS imaging from a single catheter. The system is compatible with the TVC Insight™ Catheter Kit (TVC-C195-20) and TVC Insight Hydrophilic Catheter Kit (TVC-C195-22). The system can be configured for Extended Bandwidth™ making the system compatible with the TVC Insight XB™ Extended Bandwidth NIRS-IVUS Catheter Kit (TVC-C195-32) that provides NIRS and 50MHz rotational IVUS imaging. Non-RoHsIndications for Use:1. The TVC Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures. TVC Imaging System™ INFRAREDX, INC.
42 00857595006234 TVC-C195-42 TVC-C195-42 The Dualpro™ IVUS+NIRS Imaging Catheter Kit (TVC-C195-42) is a single use, dispo The Dualpro™ IVUS+NIRS Imaging Catheter Kit (TVC-C195-42) is a single use, disposable coronary catheter and accessory kit designed for use only with the Makoto Intravascular Imaging System™ (TVC-MC10 and TVC-MC10i). The dual-modality intravascular imaging catheter combines 50 MHz Extended Bandwidth IVUS transducer and laser-based near infrared spectroscopy (NIRS) for simultaneous acquisition of vessel structure and plaque composition data— a single catheter, a single pullback, two sets of data. The Dualpro™ IVUS+NIRS Imaging Catheter features a durable hydrophilic coating for improved deliverability.Indications for Use:1. The Makoto Intravascular Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures. Dualpro™ IVUS+NIRS Imaging Catheter Kit INFRAREDX, INC.
43 00857595006227 TVC-C195-32 TVC-C195-32 Insight XB™ Catheter KitThe TVC Insight XB™ Extended Bandwidth™ NIRS-IVUS Cathet Insight XB™ Catheter KitThe TVC Insight XB™ Extended Bandwidth™ NIRS-IVUS Catheter Kit (TVC-C195-32) is a single use, disposable coronary catheter and accessory kit designed for use only with the TVC Imaging System™(TVC-MC9, TVC-MC9i, and properly configured TVC-MC8). The dual-modality intravascular imaging catheter combines laser-based near infrared spectroscopy (NIRS) and 50 MHz Extended Bandwidth ultrasonics for simultaneous acquisition of vessel structure and plaque composition— a single catheter, a single pullback, two sets of data. The Insight XB catheter features a 50MHz Extended Bandwidth IVUS transducer and durable hydrophilic coating for improved delivery.Indications for Use:1. The TVC Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures. TVC Insight XB™ INFRAREDX, INC.
44 00857595006210 TVC-C195-22 TVC-C195-22 Insight Hydrophilic Catheter™ Kit The TVC Insight Hydrophilic Catheter™ Kit (TVC Insight Hydrophilic Catheter™ Kit The TVC Insight Hydrophilic Catheter™ Kit (TVC-C195-22) is a single use, disposable coronary catheter and accessory kit designed for use only with the TVC Imaging System™ (TVC-MC8). The dual-modality intravascular imaging catheter combines laser-based near infrared spectroscopy (NIRS) and high fidelity 40 MHz ultrasonics for simultaneous acquisition of vessel structure and plaque composition—a single catheter, a single pullback, two sets of data. The catheter features a 40MHz wide bandwidth IVUS transducer and durable hydrophilic coating for improved delivery.Indications for Use:1. The TVC Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures. TVC Insight™ INFRAREDX, INC.
45 00857595006210 TVC-C195-22 TVC-C195-22 Insight Hydrophilic Catheter™ Kit The TVC Insight Hydrophilic Catheter™ Kit (TVC Insight Hydrophilic Catheter™ Kit The TVC Insight Hydrophilic Catheter™ Kit (TVC-C195-22) is a single use, disposable coronary catheter and accessory kit designed for use only with the TVC Imaging System™ (TVC-MC8). The dual-modality intravascular imaging catheter combines laser-based near infrared spectroscopy (NIRS) and high fidelity 40 MHz ultrasonics for simultaneous acquisition of vessel structure and plaque composition—a single catheter, a single pullback, two sets of data. The catheter features a 40MHz wide bandwidth IVUS transducer and durable hydrophilic coating for improved delivery.Indications for Use:1. The TVC Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures. TVC Insight™ INFRAREDX, INC.
46 00857595006203 TVC-C195-20 TVC-C195-20 Insight Catheter™ Kit The TVC Insight Catheter™ Kit (TVC-C195-20) is a single us Insight Catheter™ Kit The TVC Insight Catheter™ Kit (TVC-C195-20) is a single use, disposable coronary catheter and accessory kit designed for use only with the TVC Imaging System™ (TVC-MC8). The dual-modality intravascular imaging catheter combines laser-based near infrared spectroscopy (NIRS) and high fidelity 40 MHz ultrasonics for simultaneous acquisition of vessel structure and plaque composition—a single catheter, a single pullback, two sets of data. The catheter features a 40MHz wide bandwidth IVUS transducer.Indications for Use: 1. The TVC Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures. TVC Insight™ INFRAREDX, INC.
47 00857595006203 TVC-C195-20 TVC-C195-20 Insight Catheter™ Kit The TVC Insight Catheter™ Kit (TVC-C195-20) is a single us Insight Catheter™ Kit The TVC Insight Catheter™ Kit (TVC-C195-20) is a single use, disposable coronary catheter and accessory kit designed for use only with the TVC Imaging System™ (TVC-MC8). The dual-modality intravascular imaging catheter combines laser-based near infrared spectroscopy (NIRS) and high fidelity 40 MHz ultrasonics for simultaneous acquisition of vessel structure and plaque composition—a single catheter, a single pullback, two sets of data. The catheter features a 40MHz wide bandwidth IVUS transducer.Indications for Use: 1. The TVC Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures. TVC Insight™ INFRAREDX, INC.
48 00857595006005 TVC-MC8-B1 TVC-MC8-B1 Individual Sterile Barrier for TVC-MC8 or TVC-MC9 System Controller TVC Controller Sterile Barrier INFRAREDX, INC.
49 00849233017016 5084R2 5084R2 Sterile Nerve Block Busse Hospital Disposables ROBERT BUSSE & CO., INC.
50 00849233003729 1295 1295 Epidural Tray Busse Hospital Disposables ROBERT BUSSE & CO., INC.