Cobe Stopcock

• • Terminated Z-0290-2020 FDA Class II ·initiated 16 Oct 2018 ·on shared 510(k) K780271

  The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.

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

510(k) Number

K780271 ↗

FDA Product Code

DTL

Device Class

Class II

Regulation

21 CFR Part 870.4290

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Flowmeter, Optiflo Gas

  Class II

  FDA 510(k) K790546 Active Cleared 11 May 1979

• Cobe Ppd 1.9

  Class II

  FDA 510(k) K812336 Active Cleared 31 Aug 1981

• Cobe Spectra Blood Component Separator Therapeutic

  Unclassified

  FDA 510(k) K900105 Active Cleared 22 Mar 1991

• Cobe Emergency Power Source 43610-000

  Class II

  FDA 510(k) K842138 Active Cleared 3 Aug 1984

• Centry 2 Ultrafiltration Control Kit, #018762-002

  Class II

  FDA 510(k) K881062 Active Cleared 21 Apr 1988

• Cobe Rx Meter

  Class II

  FDA 510(k) K830629 Active Cleared 6 Apr 1983

See all devices from Cobe Laboratories, Inc. →