Cleared Special

EPTFE VASCULAR PROSTHESIS; SEALPTFE

K030999 · Vascutek, Ltd. · Cardiovascular
Apr 2003
Decision
9d
Days
Class 2
Risk

About This 510(k) Submission

K030999 is an FDA 510(k) clearance for the EPTFE VASCULAR PROSTHESIS; SEALPTFE, 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 April 9, 2003, 9 days after receiving the submission on March 31, 2003. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3450.

Submission Details

510(k) Number K030999 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 2003
Decision Date April 09, 2003
Days to Decision 9 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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