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FDA 510(k)

3 WAY URETHRAL IRRIGATION CATHETER

K-Number: K792719 · 1980-01-16

ApplicantVesta, Inc.
Decision Date1980-01-16
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

3 WAY URETHRAL IRRIGATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Vesta, Inc.. It received FDA 510(k) clearance on 1980-01-16 under 510(k) number K792719. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3 WAY URETHRAL IRRIGATION CATHETER?

3 WAY URETHRAL IRRIGATION CATHETER is a medical device that received FDA 510(k) clearance on 1980-01-16. The listed applicant is Vesta, Inc.. The 510(k) number is K792719.

When did 3 WAY URETHRAL IRRIGATION CATHETER receive FDA 510(k) clearance?

3 WAY URETHRAL IRRIGATION CATHETER received FDA 510(k) clearance on 1980-01-16, under 510(k) number K792719.

Who is the listed applicant for 3 WAY URETHRAL IRRIGATION CATHETER?

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

What is the FDA product code for 3 WAY URETHRAL IRRIGATION CATHETER?

The FDA product code for 3 WAY URETHRAL IRRIGATION CATHETER is KOD.

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 Vesta, Inc. 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.

K834078SILICONE RUGGER DISPOSABLE YOKE-CPAPK810960NASOPHARYNGEAL AIRWAYK792018SILICONE RUBBER-BI NASOPHARYNGEAL AIR

Related Devices (Code: KOD)

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.

K251864Rubber Utility CatheterC.R. Bard, Inc.K220036Wellead Ureteral CatheterWell Lead Medical Co., Ltd.K220730allFlex Ureteral Catheters, Krait Ureteral CathetersAllwin Medical Devices, Inc.K211032Urinary Catheter 12 Fr, Urinary Catheter 16 FrUrogen Pharma, Ltd.K181979Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent CatheterTeleflexmedical, Inc.K180354UroGen Ureteral CatheterUrogen Pharma, Ltd.

Official Source

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

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