Cleared Traditional

K872157 - HALL VEIN STRIPPER
(FDA 510(k) Clearance)

K872157 · Solco Basle, Inc. · Cardiovascular
Jul 1987
Decision
33d
Days
Class 2
Risk

K872157 is an FDA 510(k) clearance for the HALL VEIN STRIPPER. This device is classified as a Stripper, Vein, External (Class II — Special Controls, product code DWQ).

Submitted by Solco Basle, Inc. (Wilton, US). The FDA issued a Cleared decision on July 7, 1987, 33 days after receiving the submission on June 4, 1987.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4885.

Submission Details

510(k) Number K872157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1987
Decision Date July 07, 1987
Days to Decision 33 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary

Device Classification

Product Code DWQ — Stripper, Vein, External
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4885