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510(k) K110980

CENTRIMAG RETURN CANNULA KIT by Levitronix, LLC — Product Code DWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2011
Date Received
April 7, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4210
Review Panel
CV
Submission Type

Other clearances by Levitronix, LLC

  • K110983 — CENTRIMAG DRAINAGE CANNULA KIT (June 20, 2011)
  • 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)
  • 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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  • K253671 — Dual Stage Venous Cannulae (January 30, 2026)
  • K253998 — Clearview Intracoronary Shunts (January 20, 2026)
  • K253106 — AngioVac Cannula (October 24, 2025)
  • K250283 — RAP Femoral Venous Cannulae (July 10, 2025)
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  • K251258 — MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula (June 20, 2025)
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