GUIDE-TECH ENCAPSULATED GUIDEWIRE— 510(k) K926039

Name: FDA 510(k) clearance K926039
Creator: U.S. Food and Drug Administration
Published: 1993-08-05

Substantially Equivalent

Cape Tech Medical Products

FDA 510(k) clearance K926039 for GUIDE-TECH ENCAPSULATED GUIDEWIRE, Substantially Equivalent on 1993-08-05. Applicant: Cape Tech Medical Products. Device class: 2.

Clearance details

Applicant: Cape Tech Medical Products
Product code: Code KNY
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1992-12-01
Decision date: 1993-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Falmouth, MA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.