Company ยท US
Levitronix, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2011. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 20, 2011 | K110983 | CENTRIMAG DRAINAGE CANNULA KIT Levitronix, LLC | DWF |
| Jun 20, 2011 | K110980 | CENTRIMAG RETURN CANNULA KIT Levitronix, LLC | DWF |
| Aug 27, 2010 | K102129 | LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR Levitronix, LLC | DWA |
| Jan 13, 2010 | K093832 | LEVITRONIX CENTRIMAG PRIMARY AND BACKUP CONSOLES Levitronix, LLC | DWA |
| Oct 8, 2009 | K090051 | LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052 Levitronix, LLC | KFM |
| Jan 15, 2009 | K090004 | LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLES Levitronix, LLC | DWA |
| Nov 26, 2008 | K083340 | LEVITRONIX CENTRIMAG PRIMARY CONSOLE; THORATEC CANTRIMAG PRIMARY CONSOLE Levitronix, LLC | DWA |
| Jun 19, 2008 | K081221 | LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE Levitronix, LLC | DWA |
| Jan 26, 2006 | K053630 | LEVITRONIX CENTRIMAG PRIMARY CONSOLE Levitronix, LLC | DWA |
| Sep 8, 2005 | K051209 | LEVITRONIX CENTRIMAG BACK-UP CONSOLE Levitronix, LLC | KFM |
| Mar 25, 2003 | K020271 | LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100 Levitronix, LLC | KFM |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 23, 2008 | Levitronix, Llc Levitronix CentriMag Back-Up Console
Article Number: 201-30200; extracorporeal blood circulation system. Terminated |
KFM | K051209 |
| Jul 23, 2008 | Levitronix, Llc Levitronix CentriMag Primary System,
Article Number: 201-30100; extracorporeal blood circulation system. Terminated |
KFM | K020271 |