AFFINITY HOLLOW FIBER OXYGENATOR

Oxygenator, Cardiopulmonary Bypass

AVECOR CARDIOVASCULAR, INC.

The following data is part of a premarket notification filed by Avecor Cardiovascular, Inc. with the FDA for Affinity Hollow Fiber Oxygenator.

Pre-market Notification Details

Device IDK932252
510k NumberK932252
Device Name:AFFINITY HOLLOW FIBER OXYGENATOR
ClassificationOxygenator, 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 CodeDTZ  
CFR Regulation Number870.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-05-26
Decision Date1993-11-19

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20613994375678 K932252 000
20613994375654 K932252 000

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