Autotransfusion Appartus (Autolog)

• • Terminated Z-1939-2010 FDA Unclassified (pre-2012) ·initiated 21 Apr 2010 ·on shared 510(k) K972894

  The potential risks during the use of this power cord include electrical shock, delay in setup and therapy, interruption of therapy, device failure, and fires. Although Medtronic has received no reports of adverse events related to the affected cord, a failure may potentially lead to serious adverse health consequences, depending on the device, and therapy being interrupted. This Field Notificatio

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

510(k) Number

K972894 ↗

FDA Product Code

CAC

Device Class

Class II

Regulation

21 CFR Part 868.5830

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Heptrac Electronic Quality Control

  Class II

  FDA 510(k) K981815 Active Cleared 30 Jul 1998

• Modification of Autotransfusion Apparatus (Autolog)

  Class II

  FDA 510(k) K982755 Active Cleared 20 Aug 1998