KAYAK HYDROPHILIC GUIDE WIRES— 510(k) K014195

Name: FDA 510(k) clearance K014195
Creator: U.S. Food and Drug Administration
Published: 2002-03-19

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K014195 for KAYAK HYDROPHILIC GUIDE WIRES, Substantially Equivalent on 2002-03-19. Applicant: Boston Scientific Corp. Device class: 2.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code DOX
Device class: Class 2
Regulation: 21 CFR 862.3550
Advisory panel: Clinical Toxicology
Date received: 2001-12-21
Decision date: 2002-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maple Grove, MN, US

Download summary PDF View on FDA.gov ↗

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