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510(k) K051209

LEVITRONIX CENTRIMAG BACK-UP CONSOLE by Levitronix, LLC — Product Code KFM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 2005
Date Received
May 11, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Device Class
Class II
Regulation Number
870.4360
Review Panel
CV
Submission Type

Other clearances by Levitronix, LLC

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  • K093832 — LEVITRONIX CENTRIMAG PRIMARY AND BACKUP CONSOLES (January 13, 2010)
  • K090051 — LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052 (October 8, 2009)
  • K090004 — LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLES (January 15, 2009)
  • K083340 — LEVITRONIX CENTRIMAG PRIMARY CONSOLE; THORATEC CANTRIMAG PRIMARY CONSOLE (November 26, 2008)
  • K081221 — LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE (June 19, 2008)
  • K053630 — LEVITRONIX CENTRIMAG PRIMARY CONSOLE (January 26, 2006)
  • K020271 — LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100 (March 25, 2003)

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