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510(k) K053630

LEVITRONIX CENTRIMAG PRIMARY CONSOLE by Levitronix, LLC — Product Code DWA

K053630 is an FDA 510(k) premarket notification submitted by Levitronix, LLC for the device "LEVITRONIX CENTRIMAG PRIMARY CONSOLE". The FDA issued a decision of Substantially Equivalent on January 26, 2006. The device falls under product code DWA (Control, Pump Speed, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4380. Levitronix, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 2006
Date Received
December 29, 2005
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

  • K110983 — CENTRIMAG DRAINAGE CANNULA KIT (June 20, 2011)
  • K110980 — CENTRIMAG RETURN 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)
  • K051209 — LEVITRONIX CENTRIMAG BACK-UP CONSOLE (September 8, 2005)
  • K020271 — LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100 (March 25, 2003)

Other clearances for product code DWA

  • K232788 — INSPIRA ART100 (May 24, 2024)
  • K230698 — Anivia SG1000 Pump Console (April 18, 2023)
  • K221491 — Anivia SG1000 Pump Console (February 3, 2023)
  • K192838 — Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pre (April 13, 2020)
  • K200306 — CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, C (March 6, 2020)
  • K191557 — CentriMag Acute Circulatory Support System (July 10, 2019)
  • K131964 — BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE (July 24, 2013)
  • K131179 — CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR (July 18, 2013)
  • K112225 — SORIN CENTRIFUGAL PUMP 5 (CP5) (September 20, 2011)
  • K103468 — STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS) (January 20, 2011)

FDA data resources