Cleared Traditional

K162794 - Gelweave Vascular Grafts

K162794 is an FDA 510(k) clearance for Gelweave Vascular Grafts, 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 269-day FDA review.

K162794 · Vascutek, Ltd. · Cardiovascular device
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Jun 2017
Decision
269d
Days
Class 2
Risk

K162794 is an FDA 510(k) clearance for the Gelweave 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 June 30, 2017 after a review of 269 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

FDA 510(k) Submission Details - K162794

510(k) Number K162794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2016
Decision Date June 30, 2017
Days to Decision 269 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
144d slower than avg
Panel avg: 125d · This submission: 269d
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 152
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K162794.
exGraft, exGraft Carbon ePTFE Vascular Grafts
K180957 · Peca Labs · Aug 2018
HeRO Graft
K172637 · Merit Medical Systems, Inc. · Nov 2017
Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts
K162803 · Vascutek, Ltd. · Jul 2017
FUSION Vascular Graft
K153523 · Maquet Cardiovascular, LLC · Feb 2016
Spiral Flow Peripheral Vascular Graft
K150389 · Vascular Flow Technologies, Ltd. · May 2015
SPIRAL FLOW PERIPHERAL VASCULAR GRAFT
K142062 · Vascular Flow Technologies, Ltd. · Nov 2014