Levitronix, LLC

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
11
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K110983CENTRIMAG DRAINAGE CANNULA KITJune 20, 2011
K110980CENTRIMAG RETURN CANNULA KITJune 20, 2011
K102129LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITORAugust 27, 2010
K093832LEVITRONIX CENTRIMAG PRIMARY AND BACKUP CONSOLESJanuary 13, 2010
K090051LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052October 8, 2009
K090004LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLESJanuary 15, 2009
K083340LEVITRONIX CENTRIMAG PRIMARY CONSOLE; THORATEC CANTRIMAG PRIMARY CONSOLENovember 26, 2008
K081221LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLEJune 19, 2008
K053630LEVITRONIX CENTRIMAG PRIMARY CONSOLEJanuary 26, 2006
K051209LEVITRONIX CENTRIMAG BACK-UP CONSOLESeptember 8, 2005
K020271LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100March 25, 2003