CentriMag Acute Circulatory Support System

Control, Pump Speed, Cardiopulmonary Bypass

Thoratec Corporation (now Part Of Abbott)

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.

Pre-market Notification Details

Device IDK191557
510k NumberK191557
Device Name:CentriMag Acute Circulatory Support System
ClassificationControl, Pump Speed, Cardiopulmonary Bypass
Applicant Thoratec Corporation (now Part Of Abbott) 6035 Stoneridge Drive Pleasanton,  CA  94588
ContactLori Dondiego
CorrespondentLori Dondiego
Thoratec Corporation (now Part Of Abbott) 6035 Stoneridge Drive Pleasanton,  CA  94588
Product CodeDWA  
CFR Regulation Number870.4380 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-12
Decision Date2019-07-10

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