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FDA 510(k)

ViaOne Epicardial Access System

K-Number: K243928 · 2025-03-20

ApplicantCardiovia , Ltd.
Decision Date2025-03-20
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ViaOne Epicardial Access System is a medical device manufactured by Cardiovia , Ltd.. It received FDA 510(k) clearance on 2025-03-20 under approval number K243928. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ViaOne Epicardial Access System?

ViaOne Epicardial Access System is a medical device that received FDA 510(k) clearance on 2025-03-20. It is manufactured by Cardiovia , Ltd.. The 510(k) number is K243928.

When was ViaOne Epicardial Access System approved by the FDA?

ViaOne Epicardial Access System received FDA 510(k) clearance on 2025-03-20, under approval number K243928.

What company makes ViaOne Epicardial Access System?

ViaOne Epicardial Access System is manufactured by Cardiovia , Ltd..

What is the FDA product code for ViaOne Epicardial Access System?

The FDA product code for ViaOne Epicardial Access System is DYB.

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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: 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) PMID: 29988408 Regulation of Neurological Devices and Neurointerventional Endovascular Approaches for Acute Ischemic Stroke. Frontiers in neurology (2018)

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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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