FDA 510(k)

HeRO Graft

K-Number: K213845 · 2022-08-15

Decision Date2022-08-15

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 2022-08-15 under approval number K213845. 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 2022-08-15. It is manufactured by Merit Medical Systems, Inc.. The 510(k) number is K213845.

When was HeRO Graft approved by the FDA?

HeRO Graft received FDA 510(k) clearance on 2022-08-15, under approval number K213845.

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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Related Devices (Code: DSY)

K153523FUSION Vascular GraftMaquet Cardiovascular, LLC K172637HeRO GraftMerit Medical Systems, Inc. K162803Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular GraftsVascutek, Ltd. K162794Gelweave Vascular GraftsVascutek, Ltd. K180957exGraft, exGraft Carbon ePTFE Vascular GraftsPeca Labs K183613exGraft, exGraft CarbonPeca Labs

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.