COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR

Defoamer, Cardiopulmonary Bypass

COBE CARDIOVASCULAR, INC.

The following data is part of a premarket notification filed by Cobe Cardiovascular, Inc. with the FDA for Cobe Smarxt Vvr 4000 Filtered Hardshell Venous Reservoir.

Pre-market Notification Details

Device IDK002591
510k NumberK002591
Device Name:COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
ClassificationDefoamer, Cardiopulmonary Bypass
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 CodeDTP  
CFR Regulation Number870.4230 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-08-21
Decision Date2000-09-13

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