Cleared Special

K043552 - VASCUTEK PTFE SUPPORTED EPTFE VASCULAR ...

K043552 is an FDA 510(k) clearance for VASCUTEK PTFE SUPPORTED EPTFE VASCULAR ..., 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 9-day FDA review.

K043552 · Vascutek, Ltd. · Cardiovascular device
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Jan 2005
Decision
9d
Days
Class 2
Risk

K043552 is an FDA 510(k) clearance for the VASCUTEK PTFE SUPPORTED EPTFE VASCULAR PROSTHESES. Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by Vascutek, Ltd. (Ann Arbor, US). The FDA issued a Cleared decision on January 5, 2005 after a review of 9 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 - K043552

510(k) Number K043552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2004
Decision Date January 05, 2005
Days to Decision 9 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
116d faster than avg
Panel avg: 125d · This submission: 9d
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 K043552.
ADVANTA T-GRAFT
K051332 · Atrium Medical Corp. · Sep 2005
VENAFLO II VASCULAR GRAFT
K052282 · Bard Peripheral Vascular, Inc. · Sep 2005
DYNAFLO BYPASS GRAFT
K050049 · Bard Peripheral Vascular, Inc. · Jan 2005
MODIFICATION TO EPTFE GRAFT
K041528 · Vascutek, Ltd. · Sep 2004
GELWEAVE ANTE-FLO WITH COLLAR AND GELWEAVE 4 BRANCH PLEXUS WITH COLLAR
K040829 · Vascutek, Ltd. · May 2004
GELSOFT PLUS ERS
K034010 · Vascutek, Ltd. · Feb 2004