Cleared Special

VASCUTEK PTFE SUPPORTED EPTFE VASCULAR PROSTHESES

K043552 · Vascutek, Ltd. · Cardiovascular
Jan 2005
Decision
9d
Days
Class 2
Risk

About This 510(k) Submission

K043552 is an FDA 510(k) clearance for the VASCUTEK PTFE SUPPORTED EPTFE VASCULAR PROSTHESES, 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 January 5, 2005, 9 days after receiving the submission on December 27, 2004. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3450.

Submission Details

510(k) Number K043552 FDA.gov
FDA Decision Cleared SESE
Date Received December 27, 2004
Decision Date January 05, 2005
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

Similar Devices — DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

All 186
Spiral Laminar Flow? Vascular Arteriovenous Graft (AV0645)
K252277 · Vascular Flow Technologies Limited · Oct 2025
Gelweave? Vascular Prostheses
K241550 · Vascutek, Ltd. · Feb 2025
Gelsoft? Plus Vascular Prostheses
K241070 · Vascutek, Ltd. · Nov 2024
Advanta VXT Vascular Graft, Flixene Vascular Graft
K231972 · Atrium Medical Corporation · Mar 2024
GORE? PROPATEN? Vascular Graft
K240083 · W.L. Gore & Associates, Inc. · Mar 2024
exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts
K233783 · Peca Labs, Inc. · Jan 2024