Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2023-09-27 under approval 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. It is manufactured by Merit Medical Systems, Inc.. The 510(k) number is K232609.

When was Micro Ace™ Advanced Micro Access System approved by the FDA?

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

What company makes Micro Ace™ Advanced Micro Access System?

Micro Ace™ Advanced Micro Access System is manufactured by Merit Medical Systems, Inc..

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

NCT07613502 Bio Leg: Advancing Mobility NOT_YET_RECRUITING NCT03280862 DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS COMPLETED NCT04981223 Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging COMPLETED NCT07430293 Hybrid Closed-Loop Insulin Delivery After Pancreatectomy RECRUITING NCT07544654 DAREON®-NEC-1: A Study in People With Advanced Extrapulmonary Neuroendocrine Cancer to Compare Obrixtamig Plus Carboplatin and Etoposide Treatment With Standard Chemotherapy NOT_YET_RECRUITING NCT05934487 PROACTIVE-HF-2 Trial Heart Failure NYHA Class II and III RECRUITING

Related PubMed Literature

PMID: 39977258 Priorities for medical device regulatory approval: a report from the European Society of Cardiology Cardiovascular Round Table. European heart journal (2025) PMID: 38086727 [Introduction and Reflection on Novel Medical Device Regulatory Science Tool MDDT]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2023) PMID: 37288633 [Roadmap of Medical Device for Implanted Brain-computer Interface]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2023) PMID: 36476364 ScanMedicine: An online search system for medical innovation. Contemporary clinical trials (2023)

Other Devices by Merit Medical Systems, Inc.

K161921SwiftNINJA Microcatheter K162777Squirt Fluid Delivery System K161392Elation Pulmonary Balloon Dilation K160107DiamondTOUCH Inflation Device and Fluid Dispensing Syringe K151967Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis Catheter K153337Corvocet Biopsy System

View all 65 devices →

Related Devices (Code: DRE)

K161336VSI StraitSet micro-introducer kitVascular Solutions, Inc. K150932Sheath IntroducerBioteque Corp. K161333TightRail Sub-C Rotating Dilator SheathSpectranetics, Inc. K172487Coaxial Dilator Set (Micro-Introducer)Galt Medical Corp. K162389Medcomp Vessel DilatorMedcomp ( Medical Components) K170616van Andel Dilatation CatheterCook Incorporated

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.

↑