MPS 3 Myocardial Protection System

Heat-exchanger, Cardiopulmonary Bypass

Quest Medical, Inc.

The following data is part of a premarket notification filed by Quest Medical, Inc. with the FDA for Mps 3 Myocardial Protection System.

Pre-market Notification Details

Device IDK200438
510k NumberK200438
Device Name:MPS 3 Myocardial Protection System
ClassificationHeat-exchanger, Cardiopulmonary Bypass
Applicant Quest Medical, Inc. One Allentown Parkway Allen,  TX  75002
ContactTosan Onosode
CorrespondentTosan Onosode
Quest Medical, Inc. One Allentown Parkway Allen,  TX  75002
Product CodeDTR  
CFR Regulation Number870.4240 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-24
Decision Date2020-06-19

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