UROMAX ULTRA BALLOON DILATATION CATHETER— 510(k) K130804

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K130804 for UROMAX ULTRA BALLOON DILATATION CATHETER, Substantially Equivalent on 2013-05-22. Applicant: Boston Scientific Corporation.

Clearance details

Applicant: Boston Scientific Corporation
Product code: Code EZN
Advisory panel: Gastroenterology, Urology
Date received: 2013-03-25
Decision date: 2013-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marlboro, MA, 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.