Cleared Traditional

K202703 - Vascutek Gelsoft Plus ERS Vascular Graft

K202703 is the FDA 510(k) clearance for Vascutek Gelsoft Plus ERS Vascular Graft by Vascutek, Ltd.. It is a Class 2 Cardiovascular device (product code DSY) cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K202703 · Vascutek, Ltd. · Cardiovascular device
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Apr 2021
Decision
202d
Days
Class 2
Risk

K202703 is an FDA 510(k) clearance for the Vascutek Gelsoft Plus ERS Vascular Graft. 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 April 6, 2021 after a review of 202 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 K202703 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2020
Decision Date April 06, 2021
Days to Decision 202 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
77d slower than avg
Panel avg: 125d · This submission: 202d
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 92
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K202703.
HeRO Graft
K213845 · Merit Medical Systems, Inc. · Aug 2022
exGraft, exGraft Carbon
K221628 · Peca Labs · Aug 2022
HeRO Graft, HeRO Adapter
K203724 · Merit Medical Systems, Inc. · May 2021
exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft
K202471 · Peca Labs · Dec 2020
exGraft, exGraft Carbon
K183613 · Peca Labs · Apr 2019
exGraft, exGraft Carbon ePTFE Vascular Grafts
K180957 · Peca Labs · Aug 2018