Cleared Traditional

GORE? PROPATEN? Vascular Graft

K240083 · W.L. Gore & Associates, Inc. · Cardiovascular
Mar 2024
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K240083 is an FDA 510(k) clearance for the GORE? PROPATEN? 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 March 1, 2024, 50 days after receiving the submission on January 11, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3450.

Submission Details

510(k) Number K240083 FDA.gov
FDA Decision Cleared SESE
Date Received January 11, 2024
Decision Date March 01, 2024
Days to Decision 50 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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