Cobe Vvr 4000 Filtered Hardshell Venous Reservoir, Cobe Smarxt Vvr 4000 Filtered Hardshell Venous Reservoir

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

510(k) Number

K004046 ↗

FDA Product Code

DTP

Device Class

Class II

Regulation

21 CFR Part 870.4230

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Cobe Brat 2 Autologous Blood Salvage System With Crit-Line Hematocrit Sampling System

  Class II

  FDA 510(k) K991986 Active Cleared 9 Sep 1999

• Heat Exchanger Modification for Duo and Optima

  Class II

  FDA 510(k) K944267 Active Cleared 28 Apr 1995

• Cobe Patient Monitoring Products

  Class II

  FDA 510(k) K921343 Active Cleared 5 Jan 1993

• Cobe Sampling Site

  Class II

  FDA 510(k) K922484 Active Cleared 3 Dec 1992

• Cobe Cms-Fs Membrane Oxygenator

  Class II

  FDA 510(k) K926467 Active Cleared 9 Nov 1993

• Cobe Smarxt Optima Xp Surface Modified Hollow Fiber Membrane Oxygenator

  Class II

  FDA 510(k) K000255 Active Cleared 25 Apr 2000

See all devices from Cobe Cardiovascular, Inc. →