Cleared Traditional

Advanta VXT Vascular Graft, Flixene Vascular Graft

K231972 · Atrium Medical Corporation · Cardiovascular
Mar 2024
Decision
269d
Days
Class 2
Risk

About This 510(k) Submission

K231972 is an FDA 510(k) clearance for the Advanta VXT Vascular Graft, Flixene Vascular Graft, a Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (Class II — Special Controls, product code DSY), submitted by Atrium Medical Corporation (Hudson, US). The FDA issued a Cleared decision on March 28, 2024, 269 days after receiving the submission on July 3, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3450.

Submission Details

510(k) Number K231972 FDA.gov
FDA Decision Cleared SESE
Date Received July 03, 2023
Decision Date March 28, 2024
Days to Decision 269 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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