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510(k) K090004

LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLES by Levitronix, LLC — Product Code DWA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 2009
Date Received
January 2, 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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  • K102129 — LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR (August 27, 2010)
  • K093832 — LEVITRONIX CENTRIMAG PRIMARY AND BACKUP CONSOLES (January 13, 2010)
  • K090051 — LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052 (October 8, 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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