MPS MYOCARDIAL PROTECTION SYSTEM - MPS 2 CONSOLE, MODEL 5201260

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 Myocardial Protection System - Mps 2 Console, Model 5201260.

Pre-market Notification Details

Device IDK041979
510k NumberK041979
Device Name:MPS MYOCARDIAL PROTECTION SYSTEM - MPS 2 CONSOLE, MODEL 5201260
ClassificationHeat-exchanger, Cardiopulmonary Bypass
Applicant QUEST MEDICAL, INC. ONE ALLENTOWN PKWY. Allen,  TX  75002
ContactJane Ann Martin
CorrespondentJane Ann Martin
QUEST MEDICAL, INC. ONE ALLENTOWN PKWY. Allen,  TX  75002
Product CodeDTR  
CFR Regulation Number870.4240 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-07-23
Decision Date2004-09-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20634624524501 K041979 000
20634624522262 K041979 000
20634624521265 K041979 000
20634624510320 K041979 000
20634624514045 K041979 000
20634624512317 K041979 000
20634624511617 K041979 000
20634624511600 K041979 000
20634624510290 K041979 000

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