Gish Reliance Oxygenator (Model Hfo)

• • Terminated Z-0780-03 FDA Unclassified (pre-2012) ·initiated 31 Mar 2003 ·on shared 510(k) K961530

  Two reports of leakage.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K961530 ↗

FDA Product Code

DTZ

Device Class

Class II

Regulation

21 CFR Part 870.4350

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Vascular Access Port/Cath Cat.#vp-Xxxx Vasport Ser

  Class II

  FDA 510(k) K854610 Active Cleared 8 May 1986

• Cps-3000 Cardioplegia Reservoir

  Class II

  FDA 510(k) K861102 Active Cleared 28 May 1986

• Tubing Connectors Ec-2XXX Series

  Class II

  FDA 510(k) K833322 Active Cleared 16 Dec 1983

• Chest Drainage Pack, CDP-1000

  Class II

  FDA 510(k) K861103 Active Cleared 28 May 1986

• Cardiotomy/Venous Reservoir No.: Cvr Series

  Class II

  FDA 510(k) K883923 Active Cleared 4 Nov 1988

• Atr-2900DF (with Depth Filter)/Cap-35DF (with Depth Filter)

  Class II

  FDA 510(k) K936286 Active Cleared 14 Feb 1994

See all devices from Gish Biomedical, Inc. →