EQUINOX Balloon Dilatation Catheter— 510(k) K190612

Substantially Equivalent

Dornier Medtech America, Inc.

FDA 510(k) clearance K190612 for EQUINOX Balloon Dilatation Catheter, Substantially Equivalent on 2019-12-06. Applicant: Dornier Medtech America, Inc..

Clearance details

Applicant: Dornier Medtech America, Inc.
Product code: Code EZN
Advisory panel: Gastroenterology, Urology
Date received: 2019-03-11
Decision date: 2019-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kennesaw, GA, 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.