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 |