Cleared Traditional

MODIFICATION TO EPTFE GRAFT (K041528) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

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 K041528.
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