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Creganna-Tactx Steerable Sheath Set Symmetric

by Creganna Medical Devices

510(k) K131079

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 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 NumberK131079 Date1 Aug 2013ClearedStatusActive

Recalls

4 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-2532-2017 FDA Class II initiated 22 May 2017
    • Terminated Z-2530-2017 FDA Class II initiated 22 May 2017
    • Terminated Z-2531-2017 FDA Class II initiated 22 May 2017
    • Terminated Z-2529-2017 FDA Class II initiated 22 May 2017

    Lack of sterility assurance.

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  • Withdrawn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
DYB
Device Class
Class II
Regulation
21 CFR Part 870.1340
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent