Levitronix, Thoratec Centrimag Back-Up Consoles

• • Terminated Z-0103-2019 FDA Class II ·initiated 5 Sep 2018 ·on shared 510(k) K090004

  Reports of circulatory support system motor stopping. Motor stop can be attributed to a break of a wire or short circuit between wires within the electrical cable where the cable exits the motor cable bend protection.

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

510(k) Number

K090004 ↗

FDA Product Code

DWA

Device Class

Class II

Regulation

21 CFR Part 870.4380

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Levitronix Centrimag Primary Console

  Class II

  FDA 510(k) K053630 Active Cleared 26 Jan 2006

• Levitronix Centrimag Primary and Backup Consoles

  Class II

  FDA 510(k) K093832 Active Cleared 13 Jan 2010

• Centrimag Drainage Cannula Kit

  Class II

  FDA 510(k) K110983 Active Cleared 20 Jun 2011

• Levitronix 2ND Generation Centrimag Primary Console, Levitronix Monitor

  Class II

  FDA 510(k) K102129 Active Cleared 27 Aug 2010

• Levitronix Centrimag Primary Console; Thoratec Cantrimag Primary Console

  Class II

  FDA 510(k) K083340 Active Cleared 26 Nov 2008

• Levitronix Pedimag Blood Pump, Model 201-90052

  Class II

  FDA 510(k) K090051 Active Cleared 8 Oct 2009

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