BARD(R) COUDE TIP TEMPERATURE SENSING CATHETER

Catheter, Coude

C.R. BARD, INC.

The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard(r) Coude Tip Temperature Sensing Catheter.

Pre-market Notification Details

Device IDK913341
510k NumberK913341
Device Name:BARD(R) COUDE TIP TEMPERATURE SENSING CATHETER
ClassificationCatheter, Coude
Applicant C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington,  GA  30014
ContactDonna J Wilson
CorrespondentDonna J Wilson
C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington,  GA  30014
Product CodeEZC  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-07-26
Decision Date1992-01-27

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