Skip to content

Vascutek Vascular Prothesis VP1200K/50K

by Pacesetter Systems 510(k)

Active United States

510(k) K830016

Overview

The Vascutek Vascular Prothesis VP1200K/50K is a vascular graft device with a diameter of 6mm or greater, designed for use in cardiovascular procedures. It is a Class 2 medical device with product code DSY, intended to replace or repair damaged blood vessels.

This device is supplied by Pacesetter Systems and has received FDA 510(k) clearance through the Traditional pathway. The Vascutek Vascular Prothesis VP1200K/50K is regulated under 870.3450 and was cleared on December 21, 1983, after a 352-day FDA review.

AI-generated from registry data, 6 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK830016 Date21 Dec 1983ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DSY
Device Class
Class II
Regulation
21 CFR Part 870.3450
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Other devices from Pacesetter Systems

See all devices from Pacesetter Systems →

Questions

  • What is the Vascutek Vascular Prothesis VP1200K/50K used for?

    The Vascutek Vascular Prothesis VP1200K/50K is a vascular graft device with a diameter of 6mm or greater, designed for use in cardiovascular procedures to replace or repair damaged blood vessels.

  • What is the regulatory status of the Vascutek Vascular Prothesis VP1200K/50K?

    The device has received FDA 510(k) clearance through the Traditional pathway, regulated under 870.3450, and was cleared on December 21, 1983, after a 352-day FDA review.

  • How is the Vascutek Vascular Prothesis VP1200K/50K supplied?

    The Vascutek Vascular Prothesis VP1200K/50K is supplied by Pacesetter Systems. The device is a Class 2 medical device with product code DSY, intended for use in cardiovascular procedures.

  • What are the specifications of the Vascutek Vascular Prothesis VP1200K/50K?

    The Vascutek Vascular Prothesis VP1200K/50K is a vascular graft device with a diameter of 6mm or greater. It is designed for use in cardiovascular procedures and is intended to replace or repair damaged blood vessels.