Cleared Traditional

Gelweave Vascular Grafts

K162794 · Vascutek, Ltd. · Cardiovascular
Jun 2017
Decision
269d
Days
Class 2
Risk

About This 510(k) Submission

K162794 is an FDA 510(k) clearance for the Gelweave Vascular Grafts, a Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (Class II — Special Controls, product code DSY), submitted by Vascutek, Ltd. (Inchinnan, GB). The FDA issued a Cleared decision on June 30, 2017, 269 days after receiving the submission on October 4, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3450.

Submission Details

510(k) Number K162794 FDA.gov
FDA Decision Cleared SESE
Date Received October 04, 2016
Decision Date June 30, 2017
Days to Decision 269 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

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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