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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 the device name listed in this FDA 510(k) record. The listed applicant is Cardiovia , Ltd.. It received FDA 510(k) clearance on 2025-03-20 under 510(k) 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. The listed applicant is Cardiovia , Ltd.. The 510(k) number is K243928.

When did ViaOne Epicardial Access System receive FDA 510(k) clearance?

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

Who is the listed applicant for ViaOne Epicardial Access System?

The FDA 510(k) record lists Cardiovia , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: DYB)

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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