JETi™ 8F Catheter

JETi™ 8F Catheter
JETi™ - WV088F

A flexible or semi-flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction in native/stented blood vessels, native/synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) in conjunction with a syringe or dedicated suction pump system (pump not included). It may additionally be intended for infusion of fluids and/or used as a guide-catheter to facilitate introduction of a thrombectomy wire-net (not included) to remove residual thrombus. Collection containers may be included with the catheter. This is a single-use device.

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: QEZ

Device Name: Aspiration Thrombectomy Catheter

Device Class: 2

Physical State: Peripheral and/or coronary catheter

Definition: To remove thrombus from the peripheral and/or coronary vasculature through aspiration.

Submission Type ID: 1

Review Panel: CV

Review Code: N/A

Technical Method: Y

Gmp Exempt Flag: removed thrombus from the vasculature

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Peripheral and/or coronary vasculature

Regulation Number: 870.5150

Third Party Flag: N

Medical Specialty: CV

Device Id: 08717648353260

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A