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Guardian II Hemostasis Valve Guardian II Nc Hemostasis Valve

by Vascular Solutions Zerusa, Ltd.

510(k) K122301

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK122301 Date7 Sep 2012ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-1275-2016 FDA Class I initiated 4 Mar 2016

    Vascular Solutions became aware of a potential problem with the click version of the Guardian II hemostasis valves. The low pressure seal may not close properly, which may allow air to be introduced into the device and may lead to risk of an air embolism.

    • Terminated Z-0955-2013 FDA Class I initiated 27 Feb 2013

    Risk that air may be introduced into the device which may lead to an air embolism.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DTL
FDA applicant
Vascular Solutions Zerusa , Ltd.
Device Class
Class II
Regulation
21 CFR Part 870.4290
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent