Cobe Revolution Centrifugal Blood Pump with Pc, Model 050300700

• • Terminated Z-0193-2010 FDA Unclassified (pre-2012) ·initiated 25 Sep 2009

  A weakness in the plastic packaging tray could cause the tray to crack; compromising product sterility.

510(k) Number

K030462 ↗

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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See all devices from Cobe Cardiovascular, Inc. →