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FDA 510(k)

HeRO Graft, HeRO Adapter

K-Number: K203724 · 2021-05-25

ApplicantMerit Medical Systems, Inc.
Decision Date2021-05-25
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HeRO Graft, HeRO Adapter is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2021-05-25 under 510(k) 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. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K203724.

When did HeRO Graft, HeRO Adapter receive FDA 510(k) clearance?

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

Who is the listed applicant for HeRO Graft, HeRO Adapter?

The FDA 510(k) record lists Merit Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06422871PReSeRVE-HD: Observational Study of the Merit HeRO® Graft and Super HeRO® in Patients on HemodialysisRECRUITINGNCT03311451C2 CryoBalloon™ 180 Ablation System Dose De-escalation Study.ACTIVE_NOT_RECRUITINGNCT04540302The Merit WRAPSODY AV Access Efficacy Study (WAVE)COMPLETEDNCT05050799US Post-Market Surveillance Study of the Surfacer SystemRECRUITINGNCT06153667Bearing nsPVA Embolization for Uterine Artery Embolization (BETTER-UAE)RECRUITINGNCT06587282PREEMIE: Study for Treatment of PDA in Premature InfantsACTIVE_NOT_RECRUITING

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Related Devices (Code: DSY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252445Fusion Bioline Vascular GraftMaquet Cardiovascular, LLCK252277Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645)Vascular Flow Technologies LimitedK241550Gelweave™ Vascular ProsthesesVascutek, Ltd.K241070Gelsoft™ Plus Vascular ProsthesesVascutek, Ltd.K231972Advanta VXT Vascular Graft, Flixene Vascular GraftAtrium Medical CorporationK240083GORE® PROPATEN® Vascular GraftW. L. Gore & Associates, Inc.

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.

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