FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (2.25 MM-3.5 MM)— 510(k) K061332

Name: FDA 510(k) clearance K061332
Creator: U.S. Food and Drug Administration
Published: 2006-08-11

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K061332 for FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (2.25 MM-3.5 MM), Substantially Equivalent on 2006-08-11. Applicant: Boston Scientific Corp. Device class: 2.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code NFA
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2006-05-12
Decision date: 2006-08-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

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