Cleared Traditional

K023688 - LEMAITRE VASCULAR DISPOSABLE VEIN STRIPPER
(FDA 510(k) Clearance)

K023688 · LeMaitre Vascular, Inc. · General & Plastic Surgery device

Jan 2003

Decision

90d

Days

Class 1

Risk

K023688 is an FDA 510(k) clearance for the LEMAITRE VASCULAR DISPOSABLE VEIN STRIPPER. This device is classified as a Spatula, Surgical, General & Plastic Surgery (Class I - General Controls, product code GAF).

Submitted by LeMaitre Vascular, Inc. (Burlington, US). The FDA issued a Cleared decision on January 30, 2003, 90 days after receiving the submission on November 1, 2002.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number	K023688 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 01, 2002
Decision Date	January 30, 2003
Days to Decision	90 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement