Cleared Special

ATRIUM FLIXENE IFG VASCULAR GRAFT

K122138 · Atrium Medical Corp. · Cardiovascular
Aug 2012
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K122138 is an FDA 510(k) clearance for the ATRIUM FLIXENE IFG VASCULAR GRAFT, a Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (Class II — Special Controls, product code DSY), submitted by Atrium Medical Corp. (Hudson, US). The FDA issued a Cleared decision on August 17, 2012, 29 days after receiving the submission on July 19, 2012. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3450.

Submission Details

510(k) Number K122138 FDA.gov
FDA Decision Cleared SESE
Date Received July 19, 2012
Decision Date August 17, 2012
Days to Decision 29 days
Submission Type Special
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

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