The following data is part of a premarket notification filed by Thoratec Corporation (now Part Of Abbott) with the FDA for Centrimag Acute Circulatory Support System.
| Device ID | K191557 |
| 510k Number | K191557 |
| Device Name: | CentriMag Acute Circulatory Support System |
| Classification | Control, Pump Speed, Cardiopulmonary Bypass |
| Applicant | Thoratec Corporation (now Part Of Abbott) 6035 Stoneridge Drive Pleasanton, CA 94588 |
| Contact | Lori Dondiego |
| Correspondent | Lori Dondiego Thoratec Corporation (now Part Of Abbott) 6035 Stoneridge Drive Pleasanton, CA 94588 |
| Product Code | DWA |
| CFR Regulation Number | 870.4380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-12 |
| Decision Date | 2019-07-10 |