LEMAITRE RETROGRADE VALVULOTOME-MANU-SURGICA INSTR— 510(k) K850394

Name: FDA 510(k) clearance K850394
Creator: U.S. Food and Drug Administration
Published: 1985-04-24

Substantially Equivalent

Vascutech, Inc.

FDA 510(k) clearance K850394 for LEMAITRE RETROGRADE VALVULOTOME-MANU-SURGICA INSTR, Substantially Equivalent on 1985-04-24. Applicant: Vascutech, Inc.. Device class: 1.

Clearance details

Applicant: Vascutech, Inc.
Product code: Code DWS
Device class: Class 1
Regulation: 21 CFR 870.4500
Advisory panel: Cardiovascular
Date received: 1985-02-01
Decision date: 1985-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, 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.