AVECOR PRE-BYPASS FILTER

Filter, Prebypass, Cardiopulmonary Bypass

AVECOR CARDIOVASCULAR, INC.

The following data is part of a premarket notification filed by Avecor Cardiovascular, Inc. with the FDA for Avecor Pre-bypass Filter.

Pre-market Notification Details

Device IDK940126
510k NumberK940126
Device Name:AVECOR PRE-BYPASS FILTER
ClassificationFilter, Prebypass, 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 CodeKRJ  
CFR Regulation Number870.4280 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-01-10
Decision Date1994-06-28

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