Address:28 Crosby Drive, Suite 100,Bedford,MA,01730,US
Device Description : 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.
Device Class :
Duns Number: 124065421
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : 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.
Device Class :
Duns Number: 124065421
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : 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.
Device Class :
Duns Number: 124065421
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : 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.
Device Class : 2
Duns Number: 124065421
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : 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.
Device Class : 2
Duns Number: 124065421
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : 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.
Device Class : 2
Duns Number: 124065421
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : 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.
Device Class : 2
Duns Number: 124065421
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : 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.
Device Class : 2
Duns Number: 124065421
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : 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.
Device Class : 2
Duns Number: 124065421
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : 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.
Device Class : 2
Duns Number: 124065421
Premarket Exempt : Yes
Prescription Use : Yes