Cleared Traditional

K203724 - HeRO Graft

K203724 is the FDA 510(k) clearance for HeRO Graft by Merit Medical Systems, Inc.. It is a Class 2 Cardiovascular device (product code DSY) cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K203724 · Merit Medical Systems, Inc. · Cardiovascular device
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May 2021
Decision
155d
Days
Class 2
Risk

K203724 is an FDA 510(k) clearance for the HeRO Graft, HeRO Adapter. Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on May 25, 2021 after a review of 155 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 Merit Medical Systems, Inc. devices

Submission Details

510(k) Number K203724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2020
Decision Date May 25, 2021
Days to Decision 155 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
30d slower than avg
Panel avg: 125d · This submission: 155d
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 K203724.
GORE® ACUSEAL Vascular Graft
K231505 · W.L. Gore & Associates, Inc. · Jun 2023
HeRO Graft
K213845 · Merit Medical Systems, Inc. · Aug 2022
exGraft, exGraft Carbon
K221628 · Peca Labs · Aug 2022
Vascutek Gelsoft Plus ERS Vascular Graft
K202703 · Vascutek, Ltd. · Apr 2021
exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft
K202471 · Peca Labs · Dec 2020
exGraft, exGraft Carbon
K183613 · Peca Labs · Apr 2019