# Levitronix, LLC

- Location (FDA's records): Waltham, MA
- FDA decisions: 11 (2003–2011): 11 510(k) clearances
- Product codes: DWA (6), KFM (3), DWF (2)
- Predicates its devices cite: 16 (11 its own); citations of its devices by later devices: 22 (11 its own)
- Recalls linked to its devices: 4 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medtronic Bio-Medicus, Inc.: 2 (https://510kreport.com/company/medtronic-bio-medicus)
- Medtronic Perfusion Systems: 1 (https://510kreport.com/company/medtronic-perfusion-systems)
- Research Medical, Inc.: 1 (https://510kreport.com/company/research-medical)
- Bio Medicus, Inc.: 1 (https://510kreport.com/company/bio-medicus)

## Firms that cite its devices most
- Thoratec Corp: 4 (https://510kreport.com/company/thoratec)
- Thoratec Corporation (Now Part of Abbott): 2 (https://510kreport.com/company/thoratec-now-part-of-abbott)
- Cardiacassist, Inc.: 2 (https://510kreport.com/company/cardiacassist)
- Qura S.R.L: 1 (https://510kreport.com/company/qura)
- Orqis Medical Corporation: 1 (https://510kreport.com/company/orqis-medical)
- Maquet Cardiopulmonary, AG: 1 (https://510kreport.com/company/maquet-cardiopulmonary)

## Its most-cited devices
- K020271: Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100 (2003), cited by 10
- K083340: Levitronix Centrimag Primary Console; Thoratec Cantrimag Primary Console (2008), cited by 3
- K102129: Levitronix 2ND Generation Centrimag Primary Console, Levitronix Monitor (2010), cited by 2
- K110980: Centrimag Return Cannula Kit (2011), cited by 1
- K081221: Levitronix Centrimag Primary Console, Thoratec Centrimag Primary Console (2008), cited by 1
- K110983: Centrimag Drainage Cannula Kit (2011), cited by 1

## Recent decisions
- K110980: Centrimag Return Cannula Kit (Jun 20, 2011)
- K110983: Centrimag Drainage Cannula Kit (Jun 20, 2011)
- K102129: Levitronix 2ND Generation Centrimag Primary Console, Levitronix Monitor (Aug 27, 2010)
- K093832: Levitronix Centrimag Primary and Backup Consoles (Jan 13, 2010)
- K090051: Levitronix Pedimag Blood Pump, Model 201-90052 (Oct 8, 2009)
- K090004: Levitronix, Thoratec Centrimag Back-UP Consoles (Jan 15, 2009)
- K083340: Levitronix Centrimag Primary Console; Thoratec Cantrimag Primary Console (Nov 26, 2008)
- K081221: Levitronix Centrimag Primary Console, Thoratec Centrimag Primary Console (Jun 19, 2008)

Source page: https://510kreport.com/company/levitronix