Cleared Special

K092863 - MAXIFLO

K092863 is an FDA 510(k) clearance for MAXIFLO, 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 21-day FDA review.

K092863 · Vascutek, Ltd. · Cardiovascular device
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Oct 2009
Decision
21d
Days
Class 2
Risk

K092863 is an FDA 510(k) clearance for the MAXIFLO, TAPERFLO. 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 October 8, 2009 after a review of 21 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 - K092863

510(k) Number K092863 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2009
Decision Date October 08, 2009
Days to Decision 21 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
104d faster than avg
Panel avg: 125d · This submission: 21d
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 K092863.
EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDARD WALL,THIN WALL
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K093817 · Vascutek, Ltd. · Jan 2010
VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTS
K091778 · Vascutek, Ltd. · Aug 2009
VASCUTEK BRANCHED GELWEAVE
K090987 · Vascutek, Ltd. · Jun 2009
PTFE FLIXENE GRADUATED WALL GRAFT
K071923 · Atrium Medical Corp. · Aug 2007