Cleared Traditional

GORE? ACUSEAL Vascular Graft

K233551 · W.L. Gore & Associates, Inc. · Cardiovascular
Dec 2023
Decision
46d
Days
Class 2
Risk

About This 510(k) Submission

K233551 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 December 19, 2023, 46 days after receiving the submission on November 3, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3450.

Submission Details

510(k) Number K233551 FDA.gov
FDA Decision Cleared SESE
Date Received November 03, 2023
Decision Date December 19, 2023
Days to Decision 46 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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