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FDA 510(k)

Volta AF-Xplorer II

K-Number: K251518 · 2025-09-12

ApplicantVolta Medical
Decision Date2025-09-12
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Volta AF-Xplorer II is a medical device manufactured by Volta Medical. It received FDA 510(k) clearance on 2025-09-12 under approval number K251518. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Volta AF-Xplorer II?

Volta AF-Xplorer II is a medical device that received FDA 510(k) clearance on 2025-09-12. It is manufactured by Volta Medical. The 510(k) number is K251518.

When was Volta AF-Xplorer II approved by the FDA?

Volta AF-Xplorer II received FDA 510(k) clearance on 2025-09-12, under approval number K251518.

What company makes Volta AF-Xplorer II?

Volta AF-Xplorer II is manufactured by Volta Medical.

What is the FDA product code for Volta AF-Xplorer II?

The FDA product code for Volta AF-Xplorer II is DQK.

Other Devices by Volta Medical

K201298VX1 K232616Volta AF-Xplorer K223516VX1+ K243812Volta AF-Xplorer

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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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