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FDA 510(k)

BARDEX I.C. PEDIATRIC FOLEY CATHETER

K-Number: K993464 · 1999-12-10

ApplicantC.R. Bard, Inc.
Decision Date1999-12-10
Product CodeMJC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BARDEX I.C. PEDIATRIC FOLEY CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 1999-12-10 under 510(k) number K993464. The device is classified under product code MJC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BARDEX I.C. PEDIATRIC FOLEY CATHETER?

BARDEX I.C. PEDIATRIC FOLEY CATHETER is a medical device that received FDA 510(k) clearance on 1999-12-10. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K993464.

When did BARDEX I.C. PEDIATRIC FOLEY CATHETER receive FDA 510(k) clearance?

BARDEX I.C. PEDIATRIC FOLEY CATHETER received FDA 510(k) clearance on 1999-12-10, under 510(k) number K993464.

Who is the listed applicant for BARDEX I.C. PEDIATRIC FOLEY CATHETER?

The FDA 510(k) record lists C.R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BARDEX I.C. PEDIATRIC FOLEY CATHETER?

The FDA product code for BARDEX I.C. PEDIATRIC FOLEY CATHETER is MJC.

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Related Devices (Code: MJC)

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K233094Wellead® Latex Foley CatheterWell Lead Medical (Hainan) Co., Ltd.K040658BARDEX I.C. LATEX FOLEY CATHETERC.R. Bard, Inc.K033477HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KITRochester Medical Corp.K000251SPECTRUM SILICONE FOLEY CATHETERCook Urological, Inc.K001143RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETERRochester Medical Corp.K984136BARDEX LUBRI-SIL I.C. FOLEY CATHETERBard Medical Div.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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