AFFINITY BLOOD PUMP SYSTEM

Console, Heart-lung Machine, Cardiopulmonary Bypass

AVECOR CARDIOVASCULAR, INC.

The following data is part of a premarket notification filed by Avecor Cardiovascular, Inc. with the FDA for Affinity Blood Pump System.

Pre-market Notification Details

Device IDK964017
510k NumberK964017
Device Name:AFFINITY BLOOD PUMP SYSTEM
ClassificationConsole, Heart-lung Machine, 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 CodeDTQ  
CFR Regulation Number870.4220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-10-07
Decision Date1997-08-05
Summary:summary

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