KAMINSKY COMBINATION STENT & INJECTION CATHETER— 510(k) K865085

Name: FDA 510(k) clearance K865085
Creator: U.S. Food and Drug Administration
Published: 1987-03-25

Substantially Equivalent

Van-Tec, Inc.

FDA 510(k) clearance K865085 for KAMINSKY COMBINATION STENT & INJECTION CATHETER, Substantially Equivalent on 1987-03-25. Applicant: Van-Tec, Inc.. Device class: 2.

Clearance details

Applicant: Van-Tec, Inc.
Product code: Code FAD
Device class: Class 2
Regulation: 21 CFR 876.4620
Advisory panel: Gastroenterology, Urology
Date received: 1986-12-30
Decision date: 1987-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spencer, IN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FAD

product code FAD

Death: 2
Injury: 858
Malfunction: 2,651
Other: 1
Total: 3,512

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.