VAN-TEC ONE STEP URETERAL DILATATION CATHETER— 510(k) K870697

Substantially Equivalent

Van-Tec, Inc.

FDA 510(k) clearance K870697 for VAN-TEC ONE STEP URETERAL DILATATION CATHETER, Substantially Equivalent on 1987-03-10. Applicant: Van-Tec, Inc..

Clearance details

Applicant: Van-Tec, Inc.
Product code: Code EZN
Advisory panel: Gastroenterology, Urology
Date received: 1987-02-19
Decision date: 1987-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spencer, IN, 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.