MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING— 510(k) K953691

Substantially Equivalent

Meadox Medicals, Div. Boston Scientific Corp.

FDA 510(k) clearance K953691 for MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING, Substantially Equivalent on 1995-10-16. Applicant: Meadox Medicals, Div. Boston Scientific Corp..

Clearance details

Applicant: Meadox Medicals, Div. Boston Scientific Corp.
Product code: Code EZN
Advisory panel: Gastroenterology, Urology
Date received: 1995-08-08
Decision date: 1995-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakland, NJ, 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.