HEAT EXCHANGER MODIFICATION FOR DUO AND OPTIMA

Heat-exchanger, Cardiopulmonary Bypass

COBE CARDIOVASCULAR, INC.

The following data is part of a premarket notification filed by Cobe Cardiovascular, Inc. with the FDA for Heat Exchanger Modification For Duo And Optima.

Pre-market Notification Details

Device IDK944267
510k NumberK944267
Device Name:HEAT EXCHANGER MODIFICATION FOR DUO AND OPTIMA
ClassificationHeat-exchanger, Cardiopulmonary Bypass
Applicant COBE CARDIOVASCULAR, INC. 14401 WEST 65TH WAY Arvada,  CO  80004
ContactMary L Armstrong
CorrespondentMary L Armstrong
COBE CARDIOVASCULAR, INC. 14401 WEST 65TH WAY Arvada,  CO  80004
Product CodeDTR  
CFR Regulation Number870.4240 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-09-01
Decision Date1995-04-28

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