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FDA 510(k)

Bard Vertus Foley Catheter

K-Number: K180781 · 2018-09-19

ApplicantC.R. Bard, Inc.
Decision Date2018-09-19
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Bard Vertus Foley Catheter is a medical device manufactured by C.R. Bard, Inc.. It received FDA 510(k) clearance on 2018-09-19 under approval number K180781. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bard Vertus Foley Catheter?

Bard Vertus Foley Catheter is a medical device that received FDA 510(k) clearance on 2018-09-19. It is manufactured by C.R. Bard, Inc.. The 510(k) number is K180781.

When was Bard Vertus Foley Catheter approved by the FDA?

Bard Vertus Foley Catheter received FDA 510(k) clearance on 2018-09-19, under approval number K180781.

What company makes Bard Vertus Foley Catheter?

Bard Vertus Foley Catheter is manufactured by C.R. Bard, Inc..

What is the FDA product code for Bard Vertus Foley Catheter?

The FDA product code for Bard Vertus Foley Catheter is EZL.

Related Clinical Trials

NCT07214948 Open, Randomized Feasibility Trial on the Safety and Performance of the INGA Catheter for Labor Induction NOT_YET_RECRUITING NCT02932319 Outpatient Foley Catheter for Induction of Labor in Nulliparous for Prolonged Pregnancy COMPLETED NCT05931887 Evaluation of the Novel Silq ClearTract Catheter in Patients With Chronic Urinary Retention COMPLETED

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Related Devices (Code: EZL)

K153655Accuryn Monitoring SystemPotrero Medical, Inc. K161770Rusch Silicone Foley CatheterTeleflexmedical, Inc. K162989Rusch Simplastic Foley CathetersTeleflexmedical, Inc. K181616PSM 3-Way Silicone Foley CatheterPathway, LLC K181814AMSure Pre-filled Syringe for Balloon Inflation with Sterile WaterAmsino International, Inc. K173657Radiance(TM) Clear Sharklet(R) Silicone Foley CatheterCook Incorporated

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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