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

Control, Pump Speed, Cardiopulmonary Bypass

Abbott (formerly Thoratec Corporation)

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.

Pre-market Notification Details

Device IDK200306
510k NumberK200306
Device Name:CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit
ClassificationControl, Pump Speed, Cardiopulmonary Bypass
Applicant Abbott (formerly Thoratec Corporation) 6035 Stoneridge Drive Pleasanton,  CA  94588
ContactBindya Gadhia
CorrespondentBindya Gadhia
Abbott (formerly Thoratec Corporation) 6035 Stoneridge Drive Pleasanton,  CA  94588
Product CodeDWA  
CFR Regulation Number870.4380 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyCardiovascular
510k Review PanelCardiovascular
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-06
Decision Date2020-03-06

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