DISPOSABLE OPTICAL VALVULOTOME— 510(k) K924075

Name: FDA 510(k) clearance K924075
Creator: U.S. Food and Drug Administration
Published: 1993-02-08

Substantially Equivalent

Endovascular, Inc.

FDA 510(k) clearance K924075 for DISPOSABLE OPTICAL VALVULOTOME, Substantially Equivalent on 1993-02-08. Applicant: Endovascular, Inc.. Device class: 2.

Clearance details

Applicant: Endovascular, Inc.
Product code: Code MGZ
Device class: Class 2
Regulation: 21 CFR 870.4885
Advisory panel: Cardiovascular
Date received: 1992-08-12
Decision date: 1993-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Costa Mesa, CA, 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.