COBE OPTIMA XP HOLLOW FIBER MEMBRANE OXYGENATOR

Oxygenator, Cardiopulmonary Bypass

COBE CARDIOVASCULAR, INC.

The following data is part of a premarket notification filed by Cobe Cardiovascular, Inc. with the FDA for Cobe Optima Xp Hollow Fiber Membrane Oxygenator.

Pre-market Notification Details

Device IDK963518
510k NumberK963518
Device Name:COBE OPTIMA XP HOLLOW FIBER MEMBRANE OXYGENATOR
ClassificationOxygenator, Cardiopulmonary Bypass
Applicant COBE CARDIOVASCULAR, INC. 14401 WEST 65TH WAY Arvada,  CO  80004
ContactMary L Armstrong
CorrespondentMary L Armstrong
COBE CARDIOVASCULAR, INC. 14401 WEST 65TH WAY Arvada,  CO  80004
Product CodeDTZ  
CFR Regulation Number870.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-09-03
Decision Date1997-12-08
Summary:summary

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