Cleared Traditional

SMITH & NEPHEW TUMESCENT CATHETER INVERSION SYSTEM, MODEL 7210023

K041453 · Smith & Nephew, Inc. · Cardiovascular
Jul 2004
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K041453 is an FDA 510(k) clearance for the SMITH & NEPHEW TUMESCENT CATHETER INVERSION SYSTEM, MODEL 7210023, a Stripper, Vein, External (Class II — Special Controls, product code DWQ), submitted by Smith & Nephew, Inc. (Andover, US). The FDA issued a Cleared decision on July 22, 2004, 51 days after receiving the submission on June 1, 2004. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4885.

Submission Details

510(k) Number K041453 FDA.gov
FDA Decision Cleared SESE
Date Received June 01, 2004
Decision Date July 22, 2004
Days to Decision 51 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

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

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