TRIACTIV FX EMBOLIC PROTECTION SYSTEM— 510(k) K061772

Name: FDA 510(k) clearance K061772
Creator: U.S. Food and Drug Administration
Published: 2006-07-11

Substantially Equivalent

Kensey Nash Corp.

FDA 510(k) clearance K061772 for TRIACTIV FX EMBOLIC PROTECTION SYSTEM, Substantially Equivalent on 2006-07-11. Applicant: Kensey Nash Corp.. Device class: 2.

Clearance details

Applicant: Kensey Nash Corp.
Product code: Code NFA
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2006-06-23
Decision date: 2006-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Exton, PA, US

Download summary PDF View on FDA.gov ↗

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