PATHWAY ACCESS SHEATH CATHETER— 510(k) K030662

Substantially Equivalent

Vertelink Corporation

FDA 510(k) clearance K030662 for PATHWAY ACCESS SHEATH CATHETER, Substantially Equivalent on 2003-09-03. Applicant: Vertelink Corporation.

Clearance details

Applicant: Vertelink Corporation
Product code: Code EZN
Advisory panel: Gastroenterology, Urology
Date received: 2003-03-03
Decision date: 2003-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mission Viejo, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EZN

product code EZN

Death: 3
Injury: 127
Total: 130

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.