MODIFICATION TO GUARDWIRE PLUS TEMPORARY OCCLUSION & ASPIRATION SYSTEM— 510(k) K014223

Name: FDA 510(k) clearance K014223
Creator: U.S. Food and Drug Administration
Published: 2002-01-25

Substantially Equivalent

Medtronic Percusurge, Inc.

FDA 510(k) clearance K014223 for MODIFICATION TO GUARDWIRE PLUS TEMPORARY OCCLUSION & ASPIRATION SYSTEM, Substantially Equivalent on 2002-01-25. Applicant: Medtronic Percusurge, Inc.. Device class: 2.

Clearance details

Applicant: Medtronic Percusurge, Inc.
Product code: Code NFA
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2001-12-26
Decision date: 2002-01-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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