FDA 510(k), K020271, LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100
FDA 510(k), K020271, LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100
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510(K) Number: K020271
Device Name: LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100
Manufacturer: FARZAD PARSAIE
Device Classification Name: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Regulation Number: KFM
Classification Product Code: 01/28/2002
Date Received: 03/25/2003
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100
Manufacturer: FARZAD PARSAIE
Device Classification Name: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Regulation Number: KFM
Classification Product Code: 01/28/2002
Date Received: 03/25/2003
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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