Cleared Traditional

Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts (K162803) - FDA 510(k) Clearance

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

K162803 · Vascutek, Ltd. · Cardiovascular device
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Jul 2017
Decision
282d
Days
Class 2
Risk

K162803 is an FDA 510(k) clearance for the Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts. Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by Vascutek, Ltd. (Inchinnan, GB). The FDA issued a Cleared decision on July 14, 2017 after a review of 282 days - an extended review cycle.

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 K162803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2016
Decision Date July 14, 2017
Days to Decision 282 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
157d slower than avg
Panel avg: 125d · This submission: 282d
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 58
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K162803.
exGraft, exGraft Carbon
K183613 · Peca Labs · Apr 2019
exGraft, exGraft Carbon ePTFE Vascular Grafts
K180957 · Peca Labs · Aug 2018
HeRO Graft
K172637 · Merit Medical Systems, Inc. · Nov 2017
GORE ACUSEAL VASCULAR GRAFT
K130215 · W.L. Gore & Associates, Inc. · Apr 2013
EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDARD WALL,THIN WALL
K113101 · Boston Scientific Corporation · Jan 2012
GORE PROPATEN VASCULAR GRAFT
K062161 · W.L. Gore & Associates, Inc. · Nov 2006