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Triactiv Fx Embolic Protection System

by Kensey Nash Corp.

510(k) K061772

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK061772 Date11 Jul 2006ClearedStatusActive

Recalls

3 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-0834-2007 FDA Unclassified (pre-2012) initiated 28 Mar 2007 on shared 510(k) K061772
    • Terminated Z-0835-2007 FDA Unclassified (pre-2012) initiated 28 Mar 2007 on shared 510(k) K061772
    • Terminated Z-0833-2007 FDA Unclassified (pre-2012) initiated 28 Mar 2007 on shared 510(k) K061772

    Insufficient wire sealing

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
NFA
Device Class
Class II
Regulation
21 CFR Part 870.1250
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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