The following data is part of a premarket notification filed by Levitronix Llc. with the FDA for Levitronix Centrimag Primary Console, Thoratec Centrimag Primary Console.
| Device ID | K081221 |
| 510k Number | K081221 |
| Device Name: | LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE |
| Classification | Control, Pump Speed, Cardiopulmonary Bypass |
| Applicant | LEVITRONIX LLC. 45 FIRST AVE. Waltham, MA 02451 |
| Contact | Susan Hamann |
| Correspondent | Susan Hamann LEVITRONIX LLC. 45 FIRST AVE. Waltham, MA 02451 |
| Product Code | DWA |
| CFR Regulation Number | 870.4380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-30 |
| Decision Date | 2008-06-19 |
| Summary: | summary |