KADIR HI-TORQUE GUIDE WIRE— 510(k) K871297

Name: FDA 510(k) clearance K871297
Creator: U.S. Food and Drug Administration
Published: 1987-04-10

Substantially Equivalent

Argon Medical Corp.

FDA 510(k) clearance K871297 for KADIR HI-TORQUE GUIDE WIRE, Substantially Equivalent on 1987-04-10. Applicant: Argon Medical Corp.. Device class: 2.

Clearance details

Applicant: Argon Medical Corp.
Product code: Code KOD
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1987-03-31
Decision date: 1987-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Athens, TX, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KOD

product code KOD

Death: 5
Injury: 1,129
Malfunction: 7,019
Total: 8,153

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.