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FDA 510(k)

VITALCARE URETHRAL CATHETER

K-Number: K021938 · 2003-04-22

ApplicantVitalcare, Inc.
Decision Date2003-04-22
Product CodeGBM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VITALCARE URETHRAL CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Vitalcare, Inc.. It received FDA 510(k) clearance on 2003-04-22 under 510(k) number K021938. The device is classified under product code GBM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITALCARE URETHRAL CATHETER?

VITALCARE URETHRAL CATHETER is a medical device that received FDA 510(k) clearance on 2003-04-22. The listed applicant is Vitalcare, Inc.. The 510(k) number is K021938.

When did VITALCARE URETHRAL CATHETER receive FDA 510(k) clearance?

VITALCARE URETHRAL CATHETER received FDA 510(k) clearance on 2003-04-22, under 510(k) number K021938.

Who is the listed applicant for VITALCARE URETHRAL CATHETER?

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

What is the FDA product code for VITALCARE URETHRAL CATHETER?

The FDA product code for VITALCARE URETHRAL CATHETER is GBM.

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 Vitalcare, 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.

K021939VITALCARE FOLEY CATHETERK023872VITALCARE URETHRAL CATHETER RED RUBBER

Related Devices (Code: GBM)

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.

K241734Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter CompactWell Lead Medical Co., Ltd.K213283GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterConvatec LimitedK211436Intermittent Catheter (Not Finalized)Hollister IncorporatedK200820SpeediCath Compact SetColoplastK192904SpeediCath Compact SetColoplastK200142SpeediCath SoftColoplast

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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