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FDA 510(k)

Micro Ace Gold Advanced Micro Access System

K-Number: K242229 · 2025-01-15

ApplicantMerit Medical Systems, Inc.
Decision Date2025-01-15
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Micro Ace Gold Advanced Micro Access System is a medical device manufactured by Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2025-01-15 under approval number K242229. 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 Gold Advanced Micro Access System?

Micro Ace Gold Advanced Micro Access System is a medical device that received FDA 510(k) clearance on 2025-01-15. It is manufactured by Merit Medical Systems, Inc.. The 510(k) number is K242229.

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

Micro Ace Gold Advanced Micro Access System received FDA 510(k) clearance on 2025-01-15, under approval number K242229.

What company makes Micro Ace Gold Advanced Micro Access System?

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

What is the FDA product code for Micro Ace Gold Advanced Micro Access System?

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

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Related PubMed Literature

PMID: 40965839 A multi-stakeholder perspective on medical devices for children and adolescents with type 1 diabetes: huge unmet needs for the smallest. Journal of pediatric endocrinology & metabolism : JPEM (2025) PMID: 39977258 Priorities for medical device regulatory approval: a report from the European Society of Cardiology Cardiovascular Round Table. European heart journal (2025)

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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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