AFFINITY HOLLOW FIBER OXYGENATOR WITH TRILLIUM BIOPASSIVE SURFACE

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 With Trillium Biopassive Surface.

Pre-market Notification Details

Device IDK973760
510k NumberK973760
Device Name:AFFINITY HOLLOW FIBER OXYGENATOR WITH TRILLIUM BIOPASSIVE SURFACE
ClassificationOxygenator, Cardiopulmonary Bypass
Applicant AVECOR CARDIOVASCULAR, INC. 7611 NORTHLAND DR. Minneapolis,  MN  55428
ContactDennis E Steger
CorrespondentDennis E Steger
AVECOR CARDIOVASCULAR, INC. 7611 NORTHLAND DR. Minneapolis,  MN  55428
Product CodeDTZ  
CFR Regulation Number870.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-10-02
Decision Date1998-02-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20613994865971 K973760 000
20613994375630 K973760 000
20613994375623 K973760 000
20681490791100 K973760 000
20721902673331 K973760 000
20721902648896 K973760 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.