The following data is part of a premarket notification filed by Levitronix Llc. with the FDA for Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100.
| Device ID | K020271 |
| 510k Number | K020271 |
| Device Name: | LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100 |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Applicant | LEVITRONIX LLC. 85 FIRST AVE. Waltham, MA 02451 |
| Contact | Farzad Parsaie |
| Correspondent | Farzad Parsaie LEVITRONIX LLC. 85 FIRST AVE. Waltham, MA 02451 |
| Product Code | KFM |
| CFR Regulation Number | 870.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-28 |
| Decision Date | 2003-03-25 |
| Summary: | summary |