The following data is part of a premarket notification filed by Abbott (formerly Thoratec Corporation) with the FDA for Centrimag Circulatory Support System, Centrimag Return (arterial) Cannula Kit, Centrimag Drainage (venous) Cannula Kit.
Device ID | K200306 |
510k Number | K200306 |
Device Name: | CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit |
Classification | Control, Pump Speed, Cardiopulmonary Bypass |
Applicant | Abbott (formerly Thoratec Corporation) 6035 Stoneridge Drive Pleasanton, CA 94588 |
Contact | Bindya Gadhia |
Correspondent | Bindya Gadhia Abbott (formerly Thoratec Corporation) 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 | 2020-02-06 |
Decision Date | 2020-03-06 |