Medical Device Manufacturer · US , Waltham , MA

Levitronix, LLC - FDA 510(k) Cleared Devices

11 submissions · 11 cleared · Since 2003

11

Total

11

Cleared

0

Denied

FDA 510(k) Regulatory Record - Levitronix, LLC Cardiovascular ✕

11 devices

1-11 of 11

Cleared Jun 20, 2011

CENTRIMAG RETURN CANNULA KIT

Cardiovascular · 74d

Cleared Jun 20, 2011

CENTRIMAG DRAINAGE CANNULA KIT

Cardiovascular · 74d

Cleared Aug 27, 2010

LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR

Cardiovascular · 29d

Cleared Jan 13, 2010

LEVITRONIX CENTRIMAG PRIMARY AND BACKUP CONSOLES

Cardiovascular · 30d

Cleared Oct 08, 2009

LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052

Cardiovascular · 274d

Cleared Jan 15, 2009

LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLES

Cardiovascular · 13d

Cleared Nov 26, 2008

LEVITRONIX CENTRIMAG PRIMARY CONSOLE

Cardiovascular · 14d

Cleared Jun 19, 2008

LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE

Cardiovascular · 50d

Cleared Jan 26, 2006

LEVITRONIX CENTRIMAG PRIMARY CONSOLE

Cardiovascular · 28d

Cleared Sep 08, 2005

LEVITRONIX CENTRIMAG BACK-UP CONSOLE

Cardiovascular · 120d

Cleared Mar 25, 2003

LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100

Cardiovascular · 421d