510(k) K200306

CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit by Abbott (Formerly Thoratec Corporation) — Product Code DWA

K200306 is an FDA 510(k) premarket notification submitted by Abbott (Formerly Thoratec Corporation) for the device "CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit". The FDA issued a decision of Substantially Equivalent on March 6, 2020. The device falls under product code DWA (Control, Pump Speed, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4380. Abbott (Formerly Thoratec Corporation) has at least 1 other 510(k) clearance on record.