Carpentier-Edwards Flex. Annuloplasty

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K792441 ↗

FDA Product Code

KRH

Device Class

Class II

Regulation

21 CFR Part 870.3800

Advisory Committee

Cardiovascular

FDA Decision

PT

• Filter (7220&7221 Mobin-Uddin Vena Cava)

  Class II

  FDA 510(k) K760152 Active Cleared 19 Jul 1976

• Model 100 Spectraview

  Class I

  FDA 510(k) K800655 Active Cleared 16 Apr 1980

• Ac Adapter:models 9525, 9526, 9527

  Class II

  FDA 510(k) K781535 Active Cleared 15 Sep 1978

• Probe & Catheter

  Class II

  FDA 510(k) K771663 Active Cleared 20 Sep 1977

• Disposable Holder for Bioprosthesis

  Class I

  FDA 510(k) K790022 Active Cleared 15 Jan 1979

• Mod. 9542 Flow-Thru Inject. Temp. Sensor

  Class II

  FDA 510(k) K801552 Active Cleared 28 Jul 1980

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