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FDA 510(k)

Micro Ace™ Advanced Micro Access System

K-Number: K232609 · 2023-09-27

ApplicantMerit Medical Systems, Inc.
Decision Date2023-09-27
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Micro Ace™ Advanced Micro Access System 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 2023-09-27 under 510(k) number K232609. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Micro Ace™ Advanced Micro Access System?

Micro Ace™ Advanced Micro Access System is a medical device that received FDA 510(k) clearance on 2023-09-27. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K232609.

When did Micro Ace™ Advanced Micro Access System receive FDA 510(k) clearance?

Micro Ace™ Advanced Micro Access System received FDA 510(k) clearance on 2023-09-27, under 510(k) number K232609.

Who is the listed applicant for Micro Ace™ Advanced Micro Access System?

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 Micro Ace™ Advanced Micro Access System?

The FDA product code for Micro Ace™ Advanced Micro Access System is DRE.

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

Other records listing Merit Medical Systems, Inc. as applicant

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Related Devices (Code: DRE)

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.

K261310FlexTract Deflectable-Rotational Dilator Sheath SetMerit Medical Systems, Inc.K253616ProtekDilate Vascular Access KitSorin Group Italia S.R.L.K251325VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K242229Micro Ace Gold Advanced Micro Access SystemMerit Medical Systems, Inc.K241720VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K233647VersaCross Connect™ Transseptal DilatorBaylis Medical Company, 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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