Bio-Medicus Bio-Console (540 +6 more) - E

• • Terminated Z-1939-2010 FDA Unclassified (pre-2012) ·initiated 21 Apr 2010

  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

510(k) Number

K941921 ↗

FDA Product Code

DWA

Models / Variants

540

540A

B

C

D

E

550

Device Class

Class II

Regulation

21 CFR Part 870.4380

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• BPX80 Bio-Pump (BPX80)

  Class II

  FDA 510(k) K973011 Active Cleared 25 Feb 1998

• Medtronic Bio-Medicus Femoral Cannula/Introducer

  Class II

  FDA 510(k) K924642 Active Cleared 26 Mar 1993

• Bio-Probe(R) Blood Flow Monitoring Syst(Tx-50/50P)

  Class II

  FDA 510(k) K924208 Active Cleared 8 Jul 1993

• Medtronic Bio-Medicus Cannula Insertion Kit

  Class II

  FDA 510(k) K924643 Active Cleared 8 Dec 1992

• Medsat Oxygen Saturation System

  Class II

  FDA 510(k) K941922 Active Cleared 17 Feb 1995

• Medtronic Bio-Medicus Bio-Console Model 540-D

  Class II

  FDA 510(k) K914754 Active Cleared 20 May 1992

See all devices from Medtronic Bio-Medicus, Inc. →