CATH LAB MONITORING CATHETER

Catheter, Intravascular, Diagnostic

C.R. BARD, INC.

The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Cath Lab Monitoring Catheter.

Pre-market Notification Details

Device IDK884065
510k NumberK884065
Device Name:CATH LAB MONITORING CATHETER
ClassificationCatheter, Intravascular, Diagnostic
Applicant C.R. BARD, INC. ONE PARK WEST Tewksbury,  MA  01876 -1234
ContactKevin E Daly
CorrespondentKevin E Daly
C.R. BARD, INC. ONE PARK WEST Tewksbury,  MA  01876 -1234
Product CodeDQO  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-09-26
Decision Date1989-01-12

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20613994733652 K884065 000

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