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AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP

by Arrow International, Inc.

510(k) K201112

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

11 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 9 Oct 2026. What this means

Regulatory status

as of registry sync 9 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK201112 Date27 May 2020ClearedStatusActive

Recalls

11 recalls · 11 ongoing · FDA

  • 11 recalls, same reason

    • Ongoing Z-0436-2023 FDA Class I initiated 17 Oct 2022
    • Ongoing Z-0439-2023 FDA Class I initiated 17 Oct 2022
    • Ongoing Z-0441-2023 FDA Class I initiated 17 Oct 2022
    • Ongoing Z-0438-2023 FDA Class I initiated 17 Oct 2022
    • Ongoing Z-0443-2023 FDA Class I initiated 17 Oct 2022
    • Ongoing Z-0437-2023 FDA Class I initiated 17 Oct 2022
    • Ongoing Z-0440-2023 FDA Class I initiated 17 Oct 2022
    • Ongoing Z-0442-2023 FDA Class I initiated 17 Oct 2022
    • Ongoing Z-0435-2023 FDA Class I initiated 17 Oct 2022
    • Ongoing Z-0433-2023 FDA Class I initiated 17 Oct 2022
    • Ongoing Z-0434-2023 FDA Class I initiated 17 Oct 2022

    There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

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  • Withdrawn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
DSP
Device Class
Class II
Regulation
21 CFR Part 870.3535
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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