INTRALUMINAL ARTERY STRIPPER— 510(k) K913803

Name: FDA 510(k) clearance K913803
Creator: U.S. Food and Drug Administration
Published: 1992-04-24

Substantially Equivalent

Omni-Tract Surgical, Div. Minn. Scientific, Inc.

FDA 510(k) clearance K913803 for INTRALUMINAL ARTERY STRIPPER, Substantially Equivalent on 1992-04-24. Applicant: Omni-Tract Surgical, Div. Minn. Scientific, Inc.. Device class: 2.

Clearance details

Applicant: Omni-Tract Surgical, Div. Minn. Scientific, Inc.
Product code: Code DWX
Device class: Class 2
Regulation: 21 CFR 870.4875
Advisory panel: Cardiovascular
Date received: 1991-08-26
Decision date: 1992-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.