LEMAITRE-BOOKWALTER VESSEL DEVICES— 510(k) K912548

Name: FDA 510(k) clearance K912548
Creator: U.S. Food and Drug Administration
Published: 1991-09-18

Substantially Equivalent

Vascutech, Inc.

FDA 510(k) clearance K912548 for LEMAITRE-BOOKWALTER VESSEL DEVICES, Substantially Equivalent on 1991-09-18. Applicant: Vascutech, Inc.. Device class: 2.

Clearance details

Applicant: Vascutech, Inc.
Product code: Code DWP
Device class: Class 2
Regulation: 21 CFR 870.4475
Advisory panel: Cardiovascular
Date received: 1991-06-10
Decision date: 1991-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, 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.