Cleared Traditional

EXTERNAL VEIN STRIPPER

K933498 · Applied Medical Resources · Cardiovascular
Mar 1994
Decision
247d
Days
Class 2
Risk

About This 510(k) Submission

K933498 is an FDA 510(k) clearance for the EXTERNAL VEIN STRIPPER, a Stripper, Artery, Intraluminal (Class II — Special Controls, product code DWX), submitted by Applied Medical Resources (Launa Hills, US). The FDA issued a Cleared decision on March 23, 1994, 247 days after receiving the submission on July 19, 1993. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4875.

Submission Details

510(k) Number K933498 FDA.gov
FDA Decision Cleared SESE
Date Received July 19, 1993
Decision Date March 23, 1994
Days to Decision 247 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DWX — Stripper, Artery, Intraluminal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4875

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