Other products from "BIOSENSE WEBSTER INC"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 10846835009439 D129707 D129707 DQK COMPUTER, DIAGNOSTIC, PROGRAMMABLE 2 Carto 3
2 10846835000573 NI75TCJH NI75TCJH OAD catheter, percutaneous, cardiac ablation, for treatment of atrial flutter 3 NaviStar ThermoCool
3 10846835002379 ADSTK ADSTK DRF CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING 2 N/A
4 10846835022056 D134402 D134402 Interface Cable MTD Catheter, intracardiac mapping, high-density array 2 CARTO 3 System eco Interface Cable
5 10846835012620 D135305 D135305 DRF CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING 2 WEBSTER CS
6 10846835010046 D134909 D134909 DRF CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING 2 Lasso Nav
7 10846835009989 D135304 D135304 DRF CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING 2 WEBSTER CS
8 10846835009972 D135303 D135303 DRF CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING 2 WEBSTER CS
9 10846835009651 D134901 D134901 DRF CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING 2 Lasso Nav
10 10846835008913 D128709 D128709 DQK COMPUTER, DIAGNOSTIC, PROGRAMMABLE 2 N/A
11 10846835008890 D128623 D128623 DQK COMPUTER, DIAGNOSTIC, PROGRAMMABLE 2 N/A
12 10846835008647 OF63X4C010FS OF63X4C010FS DRF CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING 2 N/A
13 10846835008357 NI75TCCH NI75TCCH OAD catheter, percutaneous, cardiac ablation, for treatment of atrial flutter 3 NaviStar ThermoCool
14 10846835008333 NI75TCBH NI75TCBH OAD catheter, percutaneous, cardiac ablation, for treatment of atrial flutter 3 NaviStar ThermoCool
15 10846835008296 LN222515CT LN222515CT DRF CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING 2 Lasso
16 10846835008272 LN122515CT LN122515CT DRF CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING 2 Lasso
17 10846835006827 DLN2220CT DLN2220CT DRF CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING 2 Lasso Nav
18 10846835006797 DLN1220CT DLN1220CT DRF CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING 2 Lasso Nav
19 10846835006353 D8BRFL252RT D8BRFL252RT DRF CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING 2 N/A
20 10846835006322 D8BRDL252RT D8BRDL252RT DRF CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING 2 N/A
21 10846835006292 D8BRCG252RT D8BRCG252RT DRF CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING 2 N/A
22 10846835005912 D7PSL252RT D7PSL252RT LPB Cardiac ablation percutaneous catheter 3 N/A
23 10846835005882 D7L2030RT D7L2030RT DRF CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING 2 Lasso
24 10846835005875 D7L2025RT D7L2025RT DRF CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING 2 Lasso
25 10846835005868 D7L2020CT D7L2020CT DRF CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING 2 Lasso
26 10846835005851 D7L2015CT D7L2015CT DRF CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING 2 Lasso
27 10846835005820 D7L1025RT D7L1025RT DRF CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING 2 Lasso
28 10846835005813 D7L1020CT D7L1020CT DRF CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING 2 Lasso
29 10846835005806 D7L1015CT D7L1015CT DRF CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING 2 Lasso
30 10846835005790 D7L1012RT D7L1012RT DRF CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING 2 Lasso
31 10846835005714 D7FL252RT D7FL252RT LPB Cardiac ablation percutaneous catheter 3 N/A
32 10846835005684 D7EL252RT D7EL252RT LPB Cardiac ablation percutaneous catheter 3 N/A
33 10846835005660 D7EG252RT D7EG252RT LPB Cardiac ablation percutaneous catheter 3 N/A
34 10846835005608 D7DL252RT D7DL252RT LPB Cardiac ablation percutaneous catheter 3 N/A
35 10846835005592 D7DL252PS D7DL252PS LPB Cardiac ablation percutaneous catheter 3 N/A
36 10846835005554 D7CL252RT D7CL252RT LPB Cardiac ablation percutaneous catheter 3 N/A
37 10846835005530 D7CG252RT D7CG252RT LPB Cardiac ablation percutaneous catheter 3 N/A
38 10846835005110 D7BL252RT D7BL252RT LPB Cardiac ablation percutaneous catheter 3 N/A
39 10846835005080 D7AL252RT D7AL252RT LPB Cardiac ablation percutaneous catheter 3 N/A
40 10846835005073 D7AL252PS D7AL252PS LPB Cardiac ablation percutaneous catheter 3 N/A
41 10846835005042 D7A20131RT D7A20131RT DRF CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING 2 CRISTA CATH
42 10846835004861 D708RHISRT D708RHISRT DRF CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING 2 PARAHISIAN
43 10846835003697 C6MR10MLTCS C6MR10MLTCS OAD catheter, percutaneous, cardiac ablation, for treatment of atrial flutter 3 N/A
44 10846835003680 C6MR10EPTST C6MR10EPTST OAD catheter, percutaneous, cardiac ablation, for treatment of atrial flutter 3 N/A
45 10846835003666 C6MR10EPTRS C6MR10EPTRS OAD catheter, percutaneous, cardiac ablation, for treatment of atrial flutter 3 N/A
46 10846835003628 C6FST6MST6 C6FST6MST6 DRF CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING 2 N/A
47 10846835003420 C3FFMST12X C3FFMST12X DRF CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING 2 N/A
48 10846835003413 C3FFMST10X C3FFMST10X DRF CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING 2 N/A
49 10846835003406 C10MRMSTKDTCS C10MRMSTKDTCS OAD catheter, percutaneous, cardiac ablation, for treatment of atrial flutter 3 N/A
50 10846835003055 BN7TCJJ4L BN7TCJJ4L LPB Cardiac ablation percutaneous catheter 3 EZ Steer NAV
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13 00884838113923 795122 Software Version 9.x EPIQ CVx Ultrasound Circular Edition PHILIPS ULTRASOUND, INC.
14 00884838113916 795122 Software version 7.x EPIQ CVx Ultrasound Circular Edition PHILIPS ULTRASOUND, INC.
15 00884838113909 795121 Software version 9.X Affiniti 30 Ultrasound Circular Edition PHILIPS ULTRASOUND, INC.
16 00884838113893 795121 Software version 7.x Affiniti 30 Ultrasound Circular Edition PHILIPS ULTRASOUND, INC.
17 00884838113886 795120 Software Version 9.X EPIQ 5 Ultrasound Circular Edition PHILIPS ULTRASOUND, INC.
18 00884838113862 795119 Software version 9.X Affiniti 70 Ultrasound Circular Edition PHILIPS ULTRASOUND, INC.
19 00884838113855 795119 Software version 7.x Affiniti 70 Ultrasound Circular Edition PHILIPS ULTRASOUND, INC.
20 00884838113848 795118 9.X Affiniti 50 Ultrasound Circular Edition PHILIPS ULTRASOUND, INC.
21 00884838113831 795118 Software Version 7.X Affiniti 50 Ultrasound Circular Edition PHILIPS ULTRASOUND, INC.
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25 00884838107533 795232 EPIQ CVxi Ultrasound System PHILIPS ULTRASOUND, INC.
26 00884838107526 795231 EPIQ CVx Ultrasound System PHILIPS ULTRASOUND, INC.
27 00884838107519 795206 EPIQ 5W Ultrasound System PHILIPS ULTRASOUND, INC.
28 00884838107502 795204 EPIQ 5 Ultrasound System PHILIPS ULTRASOUND, INC.
29 00884838107489 795202 EPIQ 7W Ultrasound System PHILIPS ULTRASOUND, INC.
30 00884838107472 795122 9.0 and 9.0.x EPIQ CVX Diamond Select PHILIPS ULTRASOUND, INC.
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41 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.
42 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.
43 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.
44 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.
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.
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