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510(k) K093832

LEVITRONIX CENTRIMAG PRIMARY AND BACKUP CONSOLES by Levitronix, LLC — Product Code DWA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 2010
Date Received
December 14, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Control, Pump Speed, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4380
Review Panel
CV
Submission Type

Other clearances by Levitronix, LLC

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  • 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)
  • K051209 — LEVITRONIX CENTRIMAG BACK-UP CONSOLE (September 8, 2005)
  • K020271 — LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100 (March 25, 2003)

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