Cleared Special

VASCUTEK PTFE SUPPORTED EPTFE VASCULAR PROSTHESES (K043552) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

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

Submission Details

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
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 125d · This submission: 9d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 37
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K043552.
HeRO Graft
K172637 · Merit Medical Systems, Inc. · Nov 2017
EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDARD WALL,THIN WALL
K113101 · Boston Scientific Corporation · Jan 2012
EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED VASCULAR GRAFTS, WOVEN DOUBLE VELOUR WOVEN
K052964 · Boston Scientific Corp · Jan 2006
BARD GRAFT SIZER
K961134 · C.R. Bard, Inc. · Jun 1996
BARD EXPANDED PTFE VASCULAR GRAFT(MODIFICATION)
K954582 · C.R. Bard, Inc. · Dec 1995
BARD(R) EXPANDED PTFE VASCULAR GRAFT
K940816 · C.R. Bard, Inc. · Jun 1994