FILTERWIRE EZ (2.25 MM - 3.5 MM) EMBOLIC PROTECTION SYSTEM, MODELS 20120-190, 20120-300— 510(k) K051984

Name: FDA 510(k) clearance K051984
Creator: U.S. Food and Drug Administration
Published: 2006-04-10

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K051984 for FILTERWIRE EZ (2.25 MM - 3.5 MM) EMBOLIC PROTECTION SYSTEM, MODELS 20120-190, 20120-300, Substantially Equivalent on 2006-04-10. 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: 2005-07-22
Decision date: 2006-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

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