Levitronix, LLC
Waltham, MA, US
Levitronix, LLC appears in FDA device records in Waltham, MA. FDA records list 11 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 2 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 11 510(k) clearances for Levitronix, LLC between 2003 and 2011. The busiest year on record is 2008, with 2. The most recent is 2011, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 1 |
| 2005 | 1 |
| 2006 | 1 |
| 2008 | 2 |
| 2009 | 2 |
| 2010 | 2 |
| 2011 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K110983 | CENTRIMAG DRAINAGE CANNULA KIT | DWF | Substantially Equivalent | |
| K110980 | CENTRIMAG RETURN CANNULA KIT | DWF | Substantially Equivalent | |
| K102129 | LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR | DWA | Substantially Equivalent | |
| K093832 | LEVITRONIX CENTRIMAG PRIMARY AND BACKUP CONSOLES | DWA | Substantially Equivalent | |
| K090051 | LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052 | KFM | Substantially Equivalent | |
| K090004 | LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLES | DWA | Substantially Equivalent | |
| K083340 | LEVITRONIX CENTRIMAG PRIMARY CONSOLE; THORATEC CANTRIMAG PRIMARY CONSOLE | DWA | Substantially Equivalent | |
| K081221 | LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE | DWA | Substantially Equivalent | |
| K053630 | LEVITRONIX CENTRIMAG PRIMARY CONSOLE | DWA | Substantially Equivalent | |
| K051209 | LEVITRONIX CENTRIMAG BACK-UP CONSOLE | KFM | Substantially Equivalent | |
| K020271 | LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100 | KFM | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1902-2008 | Levitronix CentriMag Back-Up Console Article Number: 201-30200; extracorporeal blood circulation system. | Stops pumping: Interruption of CentriMag System support may occur when using a Valleylab Force FX-C Electrocautery Unit | Terminated | ||
| Z-1901-2008 | Levitronix CentriMag Primary System, Article Number: 201-30100; extracorporeal blood circulation system. | Stops pumping: Interruption of CentriMag System support may occur when using a Valleylab Force FX-C Electrocautery Unit | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain