INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054— 510(k) K100518

Name: FDA 510(k) clearance K100518
Creator: U.S. Food and Drug Administration
Published: 2010-08-31

Substantially Equivalent

Instrumed International, Inc.

FDA 510(k) clearance K100518 for INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054, Substantially Equivalent on 2010-08-31. Applicant: Instrumed International, Inc.. Device class: 2.

Clearance details

Applicant: Instrumed International, Inc.
Product code: Code DWP
Device class: Class 2
Regulation: 21 CFR 870.4475
Advisory panel: Cardiovascular
Date received: 2010-02-23
Decision date: 2010-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Schaumburg, IL, US

Download summary PDF View on FDA.gov ↗

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