FDA 510(k)

HeRO Graft

K-Number: K172637 · 2017-11-30

Decision Date2017-11-30

Product CodeDSY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

HeRO Graft is a medical device manufactured by Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2017-11-30 under approval number K172637. 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 Graft is a medical device that received FDA 510(k) clearance on 2017-11-30. It is manufactured by Merit Medical Systems, Inc.. The 510(k) number is K172637.

When was HeRO Graft approved by the FDA?

HeRO Graft received FDA 510(k) clearance on 2017-11-30, under approval number K172637.

What company makes HeRO Graft?

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

What is the FDA product code for HeRO Graft?

The FDA product code for HeRO Graft 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.