Cleared Special

K060124 - ATRIUM FLIXENE GRAFT

K060124 is an FDA 510(k) clearance for ATRIUM FLIXENE 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 71-day FDA review.

K060124 · Atrium Medical Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
71d
Days
Class 2
Risk

K060124 is an FDA 510(k) clearance for the ATRIUM FLIXENE 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 March 30, 2006 after a review of 71 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 - K060124

510(k) Number K060124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2006
Decision Date March 30, 2006
Days to Decision 71 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 125d · This submission: 71d
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 165
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K060124.
GORE PROPATEN VASCULAR GRAFT
K062161 · W.L. Gore & Associates, Inc. · Nov 2006
VASORING* VRC VASCULAR RING CONNECTOR
K061626 · Sunwei Tech Co. , Ltd. · Oct 2006
SWIRLGRAFT VASCULAR ACCESS GRAFT
K060741 · Veryan Medical Limited · Apr 2006
VASCUTEK GELWEAVE SIENA COLLARED ANTEFLO AND PLEXUS WITH RADIOPAQUE MARKERS
K060142 · Vascutek, Ltd. · Feb 2006
EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED VASCULAR GRAFTS, WOVEN DOUBLE VELOUR WOVEN
K052964 · Boston Scientific Corp · Jan 2006
SWIRLGRAFT BYPASS AND VASCULAR ACCESS GRAFTS
K051312 · Veryan Medical Limited · Nov 2005