COBE REVOLUTION

Pump, Blood, Cardiopulmonary Bypass, Non-roller Type

COBE CARDIOVASCULAR, INC.

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

Pre-market Notification Details

Device IDK011835
510k NumberK011835
Device Name:COBE REVOLUTION
ClassificationPump, Blood, Cardiopulmonary Bypass, Non-roller Type
Applicant COBE CARDIOVASCULAR, INC. 14401 WEST 65TH WAY Arvada,  CO  80004
ContactLynne Leonard
CorrespondentLynne Leonard
COBE CARDIOVASCULAR, INC. 14401 WEST 65TH WAY Arvada,  CO  80004
Product CodeKFM  
CFR Regulation Number870.4360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-06-12
Decision Date2002-02-12
Summary:summary

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