Cleared Traditional

VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTS

K091778 · Vascutek, Ltd. · Cardiovascular
Aug 2009
Decision
75d
Days
Class 2
Risk

About This 510(k) Submission

K091778 is an FDA 510(k) clearance for the VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTS, 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 August 31, 2009, 75 days after receiving the submission on June 17, 2009. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3450.

Submission Details

510(k) Number K091778 FDA.gov
FDA Decision Cleared SESE
Date Received June 17, 2009
Decision Date August 31, 2009
Days to Decision 75 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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