Cleared Traditional

K041528 - MODIFICATION TO EPTFE GRAFT

K041528 is an FDA 510(k) clearance for MODIFICATION TO EPTFE GRAFT, manufactured by Vascutek, Ltd.. The device is a Class 2 Cardiovascular device with product code DSY cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K041528 · Vascutek, Ltd. · Cardiovascular device
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Sep 2004
Decision
98d
Days
Class 2
Risk

K041528 is an FDA 510(k) clearance for the MODIFICATION TO EPTFE GRAFT. 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 September 14, 2004 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3450 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Vascutek, Ltd. devices

FDA 510(k) Submission Details - K041528

510(k) Number K041528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2004
Decision Date September 14, 2004
Days to Decision 98 days
Submission Type Traditional
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
27d faster than avg
Panel avg: 125d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K041528.
VENAFLO II VASCULAR GRAFT
K052282 · Bard Peripheral Vascular, Inc. · Sep 2005
DYNAFLO BYPASS GRAFT
K050049 · Bard Peripheral Vascular, Inc. · Jan 2005
VASCUTEK PTFE SUPPORTED EPTFE VASCULAR PROSTHESES
K043552 · Vascutek, Ltd. · Jan 2005
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
LIFESPAN REINFORCED EPTFE STRAIGHT VASCULAR GRAFTS, EXTERNALLY SUPPORTED VASCULAR GRAFTS, STEPPED VASCULAR GRAFTS
K032900 · Edwards Lifesciences, LLC · Dec 2003