Cleared Traditional

MODIFICATION TO EPTFE GRAFT

K041528 · Vascutek, Ltd. · Cardiovascular
Sep 2004
Decision
98d
Days
Class 2
Risk

About This 510(k) Submission

K041528 is an FDA 510(k) clearance for the MODIFICATION TO EPTFE GRAFT, 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 September 14, 2004, 98 days after receiving the submission on June 8, 2004. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3450.

Submission Details

510(k) Number K041528 FDA.gov
FDA Decision Cleared SESE
Date Received June 08, 2004
Decision Date September 14, 2004
Days to Decision 98 days
Submission Type Traditional
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