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FDA 510(k)

BARDEX LUBRI-SIL I.C. FOLEY CATHETER

K-Number: K984136 · 1999-02-16

ApplicantBard Medical Div.
Decision Date1999-02-16
Product CodeMJC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BARDEX LUBRI-SIL I.C. FOLEY CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Bard Medical Div.. It received FDA 510(k) clearance on 1999-02-16 under 510(k) number K984136. 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 LUBRI-SIL I.C. FOLEY CATHETER?

BARDEX LUBRI-SIL I.C. FOLEY CATHETER is a medical device that received FDA 510(k) clearance on 1999-02-16. The listed applicant is Bard Medical Div.. The 510(k) number is K984136.

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

BARDEX LUBRI-SIL I.C. FOLEY CATHETER received FDA 510(k) clearance on 1999-02-16, under 510(k) number K984136.

Who is the listed applicant for BARDEX LUBRI-SIL I.C. FOLEY CATHETER?

The FDA 510(k) record lists Bard Medical Div. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BARDEX LUBRI-SIL I.C. FOLEY CATHETER?

The FDA product code for BARDEX LUBRI-SIL I.C. FOLEY CATHETER is MJC.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Bard Medical Div. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K984084BARDEX LUBRI-SIL FOLEY CATHETERK970110BARD FLEXIBLE ENDOSCOPY INJECTION SYSTEM (651019)

Related Devices (Code: MJC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.K993464BARDEX I.C. PEDIATRIC FOLEY CATHETERC.R. Bard, Inc.

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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