Cleared Special

GORE? ACUSEAL Vascular Graft

K231505 · W.L. Gore & Associates, Inc. · Cardiovascular
Jun 2023
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K231505 is an FDA 510(k) clearance for the GORE? ACUSEAL Vascular Graft, a Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (Class II — Special Controls, product code DSY), submitted by W.L. Gore & Associates, Inc. (Phoenix, US). The FDA issued a Cleared decision on June 23, 2023, 30 days after receiving the submission on May 24, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3450.

Submission Details

510(k) Number K231505 FDA.gov
FDA Decision Cleared SESE
Date Received May 24, 2023
Decision Date June 23, 2023
Days to Decision 30 days
Submission Type Special
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

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