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FDA 510(k)

Arcadia Balloon Catheter

K-Number: K191596 · 2019-10-09

ApplicantMerit Medical Systems, Inc.
Decision Date2019-10-09
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arcadia Balloon Catheter 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 2019-10-09 under 510(k) number K191596. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arcadia Balloon Catheter?

Arcadia Balloon Catheter is a medical device that received FDA 510(k) clearance on 2019-10-09. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K191596.

When did Arcadia Balloon Catheter receive FDA 510(k) clearance?

Arcadia Balloon Catheter received FDA 510(k) clearance on 2019-10-09, under 510(k) number K191596.

Who is the listed applicant for Arcadia Balloon Catheter?

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 Arcadia Balloon Catheter?

The FDA product code for Arcadia Balloon Catheter is HRX.

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.

NCT03311451C2 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)RECRUITINGNCT06422871PReSeRVE-HD: Observational Study of the Merit HeRO® Graft and Super HeRO® in Patients on HemodialysisRECRUITINGNCT06587282PREEMIE: Study for Treatment of PDA in Premature InfantsACTIVE_NOT_RECRUITING

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Related Devices (Code: HRX)

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.

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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.

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