Cleared Traditional

GELWEAVE ANTE-FLO WITH COLLAR AND GELWEAVE 4 BRANCH PLEXUS WITH COLLAR

K040829 · Vascutek, Ltd. · Cardiovascular
May 2004
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K040829 is an FDA 510(k) clearance for the GELWEAVE ANTE-FLO WITH COLLAR AND GELWEAVE 4 BRANCH PLEXUS WITH COLLAR, a Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (Class II — Special Controls, product code DSY), submitted by Vascutek, Ltd. (Ann Arbor, US). The FDA issued a Cleared decision on May 20, 2004, 50 days after receiving the submission on March 31, 2004. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3450.

Submission Details

510(k) Number K040829 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 2004
Decision Date May 20, 2004
Days to Decision 50 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

Product Code DSY — Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.3450

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