Cleared Special

K122138 - ATRIUM FLIXENE IFG VASCULAR GRAFT

K122138 is an FDA 510(k) clearance for ATRIUM FLIXENE IFG VASCULAR GRAFT, manufactured by Atrium Medical Corp.. The device is a Class 2 Cardiovascular device with product code DSY cleared through the Special 510(k) pathway after a 29-day FDA review.

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

K122138 is an FDA 510(k) clearance for the ATRIUM FLIXENE IFG VASCULAR GRAFT. Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by Atrium Medical Corp. (Hudson, US). The FDA issued a Cleared decision on August 17, 2012 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3450 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Atrium Medical Corp. devices

FDA 510(k) Submission Details - K122138

510(k) Number K122138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

DSY Device Classification - Class 2, Special Controls

Product Code DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3450
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

All 125
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K122138.
Gelweave Vascular Grafts
K162794 · Vascutek, Ltd. · Jun 2017
GORE ACUSEAL VASCULAR GRAFT
K130215 · W.L. Gore & Associates, Inc. · Apr 2013
LIFESPAN EPTFE VASCULAR GRAFT
K130016 · LeMaitre Vascular, Inc. · Feb 2013
EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDARD WALL,THIN WALL
K113101 · Boston Scientific Corporation · Jan 2012
ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT
K102596 · Atrium Medical Corp. · Oct 2010
GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS
K093817 · Vascutek, Ltd. · Jan 2010