Cleared Special

CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit

K200306 · Abbott (Formerly Thoratec Corporation) · Cardiovascular

Mar 2020

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K200306 is an FDA 510(k) clearance for the CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit, a Control, Pump Speed, Cardiopulmonary Bypass (Class II — Special Controls, product code DWA), submitted by Abbott (Formerly Thoratec Corporation) (Pleasnaton, US). The FDA issued a Cleared decision on March 6, 2020, 29 days after receiving the submission on February 6, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4380.

Submission Details

510(k) Number	K200306 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 06, 2020
Decision Date	March 06, 2020
Days to Decision	29 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF