Cleared Special

K102596 - ATRIUM GRADUATED WALL FLIXENE AX-BIFEM ...

K102596 is an FDA 510(k) clearance for ATRIUM GRADUATED WALL FLIXENE AX-BIFEM ..., 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 26-day FDA review.

K102596 · Atrium Medical Corp. · Cardiovascular device
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Oct 2010
Decision
26d
Days
Class 2
Risk

K102596 is an FDA 510(k) clearance for the ATRIUM GRADUATED WALL FLIXENE AX-BIFEM 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 October 5, 2010 after a review of 26 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 - K102596

510(k) Number K102596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2010
Decision Date October 05, 2010
Days to Decision 26 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
99d faster than avg
Panel avg: 125d · This submission: 26d
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 K102596.
LIFESPAN EPTFE VASCULAR GRAFT
K130016 · LeMaitre Vascular, Inc. · Feb 2013
ATRIUM FLIXENE IFG VASCULAR GRAFT
K122138 · Atrium Medical Corp. · Aug 2012
EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDARD WALL,THIN WALL
K113101 · Boston Scientific Corporation · Jan 2012
GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS
K093817 · Vascutek, Ltd. · Jan 2010
MAXIFLO, TAPERFLO
K092863 · Vascutek, Ltd. · Oct 2009
VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTS
K091778 · Vascutek, Ltd. · Aug 2009