2.0MM EXPANDABLE LEMAITRE VALVULOTOME (ELV 2.0- GNT)— 510(k) K980723

Name: FDA 510(k) clearance K980723
Creator: U.S. Food and Drug Administration
Published: 1999-02-12

Substantially Equivalent

Vascutech, Inc.

FDA 510(k) clearance K980723 for 2.0MM EXPANDABLE LEMAITRE VALVULOTOME (ELV 2.0- GNT), Substantially Equivalent on 1999-02-12. Applicant: Vascutech, Inc.. Device class: 2.

Clearance details

Applicant: Vascutech, Inc.
Product code: Code MGZ
Device class: Class 2
Regulation: 21 CFR 870.4885
Advisory panel: Cardiovascular
Date received: 1998-02-24
Decision date: 1999-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burlington, MA, 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.