URETERAL BALLOON DILATATION CATHETER— 510(k) K903813

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K903813 for URETERAL BALLOON DILATATION CATHETER, Substantially Equivalent on 1990-11-07. Applicant: Boston Scientific Corp.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code EZN
Advisory panel: Gastroenterology, Urology
Date received: 1990-08-20
Decision date: 1990-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, 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.