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Tandemheart Pump

by Cardiacassist, Inc. 510(k)

Active United States

510(k) K110493

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK110493 Date20 Sep 2011ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

8 recalls · FDA

  • 8 recalls, same reason

    • Terminated Z-1950-2020 FDA Class II initiated 6 Mar 2020
    • Terminated Z-1954-2020 FDA Class II initiated 6 Mar 2020
    • Terminated Z-1949-2020 FDA Class II initiated 6 Mar 2020
    • Terminated Z-1948-2020 FDA Class II initiated 6 Mar 2020
    • Terminated Z-1951-2020 FDA Class II initiated 6 Mar 2020
    • Terminated Z-1955-2020 FDA Class II initiated 6 Mar 2020
    • Terminated Z-1953-2020 FDA Class II initiated 6 Mar 2020
    • Terminated Z-1952-2020 FDA Class II initiated 6 Mar 2020

    Failure to prime due to an assembly error

Specification

510(k)

510(k) Number
FDA Product Code
KFM
Device Class
Class II
Regulation
21 CFR Part 870.4360
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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