Cleared Special

K060142 - VASCUTEK GELWEAVE SIENA COLLARED ANTEFL...

K060142 is an FDA 510(k) clearance for VASCUTEK GELWEAVE SIENA COLLARED ANTEFL..., manufactured by Vascutek, Ltd.. The device is a Class 2 Cardiovascular device with product code DSY cleared through the Special 510(k) pathway after a 19-day FDA review.

K060142 · Vascutek, Ltd. · Cardiovascular device
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Feb 2006
Decision
19d
Days
Class 2
Risk

K060142 is an FDA 510(k) clearance for the VASCUTEK GELWEAVE SIENA COLLARED ANTEFLO AND PLEXUS WITH RADIOPAQUE MARKERS. Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by Vascutek, Ltd. (Renfrewshire, Glasgow, GB). The FDA issued a Cleared decision on February 7, 2006 after a review of 19 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 Vascutek, Ltd. devices

FDA 510(k) Submission Details - K060142

510(k) Number K060142 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2006
Decision Date February 07, 2006
Days to Decision 19 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
106d faster than avg
Panel avg: 125d · This submission: 19d
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 K060142.
PTFE FLIXENE GRADUATED WALL GRAFT
K071923 · Atrium Medical Corp. · Aug 2007
GORE PROPATEN VASCULAR GRAFT
K062161 · W.L. Gore & Associates, Inc. · Nov 2006
ATRIUM FLIXENE GRAFT
K060124 · Atrium Medical Corp. · Mar 2006
EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED VASCULAR GRAFTS, WOVEN DOUBLE VELOUR WOVEN
K052964 · Boston Scientific Corp · Jan 2006
ADVANTA T-GRAFT
K051332 · Atrium Medical Corp. · Sep 2005
VENAFLO II VASCULAR GRAFT
K052282 · Bard Peripheral Vascular, Inc. · Sep 2005