Cleared Special

MAXIFLO, TAPERFLO

K092863 · Vascutek, Ltd. · Cardiovascular
Oct 2009
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K092863 is an FDA 510(k) clearance for the MAXIFLO, TAPERFLO, a Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (Class II — Special Controls, product code DSY), submitted by Vascutek, Ltd. (Renfrewshire, Glasgow, GB). The FDA issued a Cleared decision on October 8, 2009, 21 days after receiving the submission on September 17, 2009. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3450.

Submission Details

510(k) Number K092863 FDA.gov
FDA Decision Cleared SESE
Date Received September 17, 2009
Decision Date October 08, 2009
Days to Decision 21 days
Submission Type Special
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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