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)

PATHWAY ACCESS SHEATH CATHETER

K-Number: K030662 · 2003-09-03

ApplicantVertelink Corporation
Decision Date2003-09-03
Product CodeEZN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PATHWAY ACCESS SHEATH CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Vertelink Corporation. It received FDA 510(k) clearance on 2003-09-03 under 510(k) number K030662. The device is classified under product code EZN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PATHWAY ACCESS SHEATH CATHETER?

PATHWAY ACCESS SHEATH CATHETER is a medical device that received FDA 510(k) clearance on 2003-09-03. The listed applicant is Vertelink Corporation. The 510(k) number is K030662.

When did PATHWAY ACCESS SHEATH CATHETER receive FDA 510(k) clearance?

PATHWAY ACCESS SHEATH CATHETER received FDA 510(k) clearance on 2003-09-03, under 510(k) number K030662.

Who is the listed applicant for PATHWAY ACCESS SHEATH CATHETER?

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

What is the FDA product code for PATHWAY ACCESS SHEATH CATHETER?

The FDA product code for PATHWAY ACCESS SHEATH CATHETER is EZN.

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 Vertelink Corporation 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.

K032102VERTELINK KOBRA SPINAL FIXATION SYSTEMK030734PATHWAY ACCESS SHEATH CATHETER

Related Devices (Code: EZN)

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.

K250910Optilume® High Pressure Urological Balloon Dilation CatheterUrotronic, Inc.K220781ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer CatheterAllwin Medical Devices, Inc.K201007In-Ka Ureteral Balloon Dilatation CatheterColoplast Corp.K190612EQUINOX Balloon Dilatation CatheterDornier Medtech America, Inc.K173654Ureteral Dilator Sets, Ureteral DilatorsCook IncorporatedK180756Safety Wire Guide IntroducerCook 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.

↑