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Combicath Catheter

by Plastimed Laboratoire Pharmaceutique

510(k) K974642

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

6 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 NumberK974642 Date13 Mar 1998ClearedStatusActive

Recalls

6 recalls · FDA

  • 6 recalls, same reason

    • Terminated Z-2487-2020 FDA Class II initiated 27 May 2020
    • Terminated Z-2490-2020 FDA Class II initiated 27 May 2020
    • Terminated Z-2491-2020 FDA Class II initiated 27 May 2020
    • Terminated Z-2489-2020 FDA Class II initiated 27 May 2020
    • Terminated Z-2488-2020 FDA Class II initiated 27 May 2020
    • Terminated Z-2492-2020 FDA Class II initiated 27 May 2020

    Lack of assurance of sterility

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  • Withdrawn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
EOQ
Device Class
Class II
Regulation
21 CFR Part 874.4680
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

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