VS-402 VENASEAL CLOSURE SYSTEM X5

VS
VenaSeal™ - VS-402

A collection of sterile devices intended to be used for the endovascular closure of the great saphenous vein (GSV) and associated varicosities as a treatment for varicose veins. It typically includes a surgical adhesive (e.g., cyanoacrylate), syringe, delivery catheter, dilator, introducer and a dispensing gun. The adhesive is typically delivered under ultrasonic control at prescribed intervals throughout the length of the affected vein to adhere the vessel walls together, resulting in the complete and permanent closure of the lumen. This is a single-use device.

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: PJQ

Device Name: Agent, Occluding, Vascular, Permanent

Device Class: 3

Physical State: The device consists of a polymerizing glue and delivery system for injection into the vasculature.

Definition: The device is a polymerizing agent intended for permanent occlusion of peripheral blood vessels.

Submission Type ID: 2

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: The material polymerizes in the vessel to permanently coapt or occlude the vessel.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: Peripheral vasculature

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Id: 20643169986262

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00643169986268

Package Quantity: 5

Package Discontinue Date: 12/7/2018 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: PK

Device Id: 00643169986268

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