FDA 510(k)

HeRO Graft, HeRO Adapter

K-Number: K203724 · 2021-05-25

Decision Date2021-05-25

Product CodeDSY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

HeRO Graft, HeRO Adapter is a medical device manufactured by Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2021-05-25 under approval number K203724. The device is classified under product code DSY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HeRO Graft, HeRO Adapter?

HeRO Graft, HeRO Adapter is a medical device that received FDA 510(k) clearance on 2021-05-25. It is manufactured by Merit Medical Systems, Inc.. The 510(k) number is K203724.

When was HeRO Graft, HeRO Adapter approved by the FDA?

HeRO Graft, HeRO Adapter received FDA 510(k) clearance on 2021-05-25, under approval number K203724.

What company makes HeRO Graft, HeRO Adapter?

HeRO Graft, HeRO Adapter is manufactured by Merit Medical Systems, Inc..

What is the FDA product code for HeRO Graft, HeRO Adapter?

The FDA product code for HeRO Graft, HeRO Adapter is DSY.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.