LEMAITRE VALVULOTOME II— 510(k) K946352

Substantially Equivalent

Vascutech, Inc.

FDA 510(k) clearance K946352 for LEMAITRE VALVULOTOME II, Substantially Equivalent on 1995-06-21. 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: 1994-12-30
Decision date: 1995-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Andover, MA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Vascutech, Inc.

K001621 — DARDIK CAROTID SHUNT2000-12-06
K992942 — LEMAITRE OCCLUSION CATHETER2000-04-13
K992933 — LEMAITRE IRRIGATION CATHETER2000-03-08
K992934 — LEMAITRE VENOUS THROMBECTOMY CATHETER2000-03-01
K992940 — LEMAITRE BALLOON CATHETER WITH IRRIGATION2000-02-22

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