AFFINITY VENOUS RESERVIOR BAG

Reservoir, Blood, Cardiopulmonary Bypass

AVECOR CARDIOVASCULAR, INC.

The following data is part of a premarket notification filed by Avecor Cardiovascular, Inc. with the FDA for Affinity Venous Reservior Bag.

Pre-market Notification Details

Device IDK935717
510k NumberK935717
Device Name:AFFINITY VENOUS RESERVIOR BAG
ClassificationReservoir, Blood, Cardiopulmonary Bypass
Applicant AVECOR CARDIOVASCULAR, INC. 13010 COUNTRY RD. 6 Plymouth,  MN  55441
ContactDennis E Steger
CorrespondentDennis E Steger
AVECOR CARDIOVASCULAR, INC. 13010 COUNTRY RD. 6 Plymouth,  MN  55441
Product CodeDTN  
CFR Regulation Number870.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-11-30
Decision Date1994-05-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
50613994010792 K935717 000

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