Automated Blood Cell Separators

Separator, Automated, Blood Cell, Diagnostic

COBE Cardiovascular, Inc.

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

Pre-market Notification Details

Device IDBK950065
510k NumberBK950065
Device Name:Automated Blood Cell Separators
ClassificationSeparator, Automated, Blood Cell, Diagnostic
Applicant COBE Cardiovascular, Inc. 1201 Oak Street Lakewood,  CO  80215
Product CodeGKT  
CFR Regulation Number864.9245 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-11-14
Decision Date2002-11-12

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05020583719002 BK950065 0
05020583711006 BK950065 0
35020583706300 BK950065 0
35020583706102 BK950065 0
35020583706003 BK950065 0
05020583706309 BK950065 0
05020583706101 BK950065 0
05020583706002 BK950065 0

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