BARDEX LATEX-FREE TEMPERATURE-SENSING FOLEY CATHETER (UNCOATED); BARDEX LUBRI-SIL TEMPERATURE-SENSING FOLEY CATHETER (LU

Catheter, Retention Type, Balloon

C.R. BARD, INC.

The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bardex Latex-free Temperature-sensing Foley Catheter (uncoated); Bardex Lubri-sil Temperature-sensing Foley Catheter (lu.

Pre-market Notification Details

Device IDK003289
510k NumberK003289
Device Name:BARDEX LATEX-FREE TEMPERATURE-SENSING FOLEY CATHETER (UNCOATED); BARDEX LUBRI-SIL TEMPERATURE-SENSING FOLEY CATHETER (LU
ClassificationCatheter, Retention Type, Balloon
Applicant C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington,  GA  30014
ContactGeorge C Abernathy
Product CodeEZL  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedYes
Combination ProductNo
Date Received2000-10-20
Decision Date2001-01-05

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