FILTER WIRE EZ EMBOLIC PROTECTION SYSTEM AND EZ BENT TIP RETRIEVAL SHEATH— 510(k) K032884

Name: FDA 510(k) clearance K032884
Creator: U.S. Food and Drug Administration
Published: 2004-08-06

Substantially Equivalent

Boston Scientific Epi

FDA 510(k) clearance K032884 for FILTER WIRE EZ EMBOLIC PROTECTION SYSTEM AND EZ BENT TIP RETRIEVAL SHEATH, Substantially Equivalent on 2004-08-06. Applicant: Boston Scientific Epi. Device class: 2.

Clearance details

Applicant: Boston Scientific Epi
Product code: Code NFA
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2003-09-16
Decision date: 2004-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, US

Download summary PDF View on FDA.gov ↗

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