CARDIO-COOL

Heat-exchanger, Cardiopulmonary Bypass

BIO-VASCULAR, INC.

The following data is part of a premarket notification filed by Bio-vascular, Inc. with the FDA for Cardio-cool.

Pre-market Notification Details

Device IDK860523
510k NumberK860523
Device Name:CARDIO-COOL
ClassificationHeat-exchanger, Cardiopulmonary Bypass
Applicant BIO-VASCULAR, INC. 2670 PATTON RD. Saint Paul,  MN  55113
ContactAnn M Riley
CorrespondentAnn M Riley
BIO-VASCULAR, INC. 2670 PATTON RD. Saint Paul,  MN  55113
Product CodeDTR  
CFR Regulation Number870.4240 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-02-12
Decision Date1986-04-29

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