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Transform Occlusion Balloon Catheter (Compliant and Super Compliant

by Stryker Neurovascular

510(k) K122576

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

8 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 NumberK122576 Date11 Jan 2013ClearedStatusActive

Recalls

8 recalls · FDA

  • 8 recalls, same reason

    • Terminated Z-0512-2014 FDA Class II initiated 4 Nov 2013
    • Terminated Z-0507-2014 FDA Class II initiated 4 Nov 2013
    • Terminated Z-0505-2014 FDA Class II initiated 4 Nov 2013
    • Terminated Z-0510-2014 FDA Class II initiated 4 Nov 2013
    • Terminated Z-0511-2014 FDA Class II initiated 4 Nov 2013
    • Terminated Z-0509-2014 FDA Class II initiated 4 Nov 2013
    • Terminated Z-0508-2014 FDA Class II initiated 4 Nov 2013
    • Terminated Z-0506-2014 FDA Class II initiated 4 Nov 2013

    Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.

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  • Withdrawn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
MJN
Device Class
Class II
Regulation
21 CFR Part 870.4450
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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