COBE CENTURY PERFUSION PUMP

Pump, Blood, Cardiopulmonary Bypass, Roller Type

COBE CARDIOVASCULAR, INC.

The following data is part of a premarket notification filed by Cobe Cardiovascular, Inc. with the FDA for Cobe Century Perfusion Pump.

Pre-market Notification Details

Device IDK960974
510k NumberK960974
Device Name:COBE CENTURY PERFUSION PUMP
ClassificationPump, Blood, Cardiopulmonary Bypass, Roller Type
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 CodeDWB  
CFR Regulation Number870.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-03-11
Decision Date1997-07-14
Summary:summary

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