BARDEX, LUBRI-SIL AND LUBRI-SIL IC ALL-SILICONE FOLEY CATHETERS

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, Lubri-sil And Lubri-sil Ic All-silicone Foley Catheters.

Pre-market Notification Details

Device IDK040504
510k NumberK040504
Device Name:BARDEX, LUBRI-SIL AND LUBRI-SIL IC ALL-SILICONE FOLEY CATHETERS
ClassificationCatheter, Retention Type, Balloon
Applicant C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington,  GA  30014
ContactJohn C Knorpp
CorrespondentJohn C Knorpp
C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington,  GA  30014
Product CodeEZL  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-02-27
Decision Date2004-05-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817643020308 K040504 000
00817643020292 K040504 000
00817643020193 K040504 000
00817643020186 K040504 000
00817643020179 K040504 000
00817643020162 K040504 000
00817643020155 K040504 000

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