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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 the device name listed in this FDA 510(k) record. The listed applicant is Volta Medical. It received FDA 510(k) clearance on 2025-09-12 under 510(k) 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. The listed applicant is Volta Medical. The 510(k) number is K251518.

When did Volta AF-Xplorer II receive FDA 510(k) clearance?

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

Who is the listed applicant for Volta AF-Xplorer II?

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

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

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

Related Clinical Trials

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.

NCT07621055VOLta Medical AI-software in REal-World During AF AblationRECRUITING

Other records listing Volta Medical as applicant

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.

K243812Volta AF-XplorerK232616Volta AF-XplorerK223516VX1+K201298VX1

Related Devices (Code: DQK)

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.

K253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLCK253463ILR ECG Analyzer (IM007)Implicity, Inc.K261119NorthStar Mapping System (MAP01 or MAP01-01)Imricor Medical Systems, Inc.K253088OneStim-DUO Cardiac Stimulator (MP5003-4CO)Micropace Pty, Ltd.

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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