Cleared Traditional

HeRO Graft

K213845 · Merit Medical Systems, Inc. · Cardiovascular
Aug 2022
Decision
249d
Days
Class 2
Risk

About This 510(k) Submission

K213845 is an FDA 510(k) clearance for the HeRO Graft, a Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (Class II — Special Controls, product code DSY), submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on August 15, 2022, 249 days after receiving the submission on December 9, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3450.

Submission Details

510(k) Number K213845 FDA.gov
FDA Decision Cleared SESE
Date Received December 09, 2021
Decision Date August 15, 2022
Days to Decision 249 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DSY — Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.3450

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