Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AMERICAN CATHETER, MODEL W3

K-Number: K030538 · 2003-03-10

ApplicantCatheter, LLC
Decision Date2003-03-10
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AMERICAN CATHETER, MODEL W3 is the device name listed in this FDA 510(k) record. The listed applicant is Catheter, LLC. It received FDA 510(k) clearance on 2003-03-10 under 510(k) number K030538. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMERICAN CATHETER, MODEL W3?

AMERICAN CATHETER, MODEL W3 is a medical device that received FDA 510(k) clearance on 2003-03-10. The listed applicant is Catheter, LLC. The 510(k) number is K030538.

When did AMERICAN CATHETER, MODEL W3 receive FDA 510(k) clearance?

AMERICAN CATHETER, MODEL W3 received FDA 510(k) clearance on 2003-03-10, under 510(k) number K030538.

Who is the listed applicant for AMERICAN CATHETER, MODEL W3?

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

What is the FDA product code for AMERICAN CATHETER, MODEL W3?

The FDA product code for AMERICAN CATHETER, MODEL W3 is EZD.

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

Related Devices (Code: EZD)

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.

K261418Liquick X-treme, Liquick X-treme PlusTeleflex MedicalK260737Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18).ConvatecK261658LoFric Origo Pro CoudéWellspect ABK262045Luja SoftColoplast A.S.K260394Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)Hangzhou Jimushi Meditech Co., Ltd.K253295Coude Sleeved IC; Coude Plus Sleeved ICHollister 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.

↑