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FDA 510(k)

Volta AF-Xplorer

K-Number: K232616 · 2023-09-27

ApplicantVolta Medical
Decision Date2023-09-27
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Volta AF-Xplorer is a medical device manufactured by Volta Medical. It received FDA 510(k) clearance on 2023-09-27 under approval number K232616. 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?

Volta AF-Xplorer is a medical device that received FDA 510(k) clearance on 2023-09-27. It is manufactured by Volta Medical. The 510(k) number is K232616.

When was Volta AF-Xplorer approved by the FDA?

Volta AF-Xplorer received FDA 510(k) clearance on 2023-09-27, under approval number K232616.

What company makes Volta AF-Xplorer?

Volta AF-Xplorer is manufactured by Volta Medical.

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

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

Other Devices by Volta Medical

K201298VX1 K223516VX1+ K251518Volta AF-Xplorer II 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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