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FDA 510(k)

VX1

K-Number: K201298 · 2020-09-16

ApplicantVolta Medical
Decision Date2020-09-16
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VX1 is the device name listed in this FDA 510(k) record. The listed applicant is Volta Medical. It received FDA 510(k) clearance on 2020-09-16 under 510(k) number K201298. 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 VX1?

VX1 is a medical device that received FDA 510(k) clearance on 2020-09-16. The listed applicant is Volta Medical. The 510(k) number is K201298.

When did VX1 receive FDA 510(k) clearance?

VX1 received FDA 510(k) clearance on 2020-09-16, under 510(k) number K201298.

Who is the listed applicant for VX1?

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 VX1?

The FDA product code for VX1 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.

K251518Volta AF-Xplorer IIK243812Volta AF-XplorerK232616Volta AF-XplorerK223516VX1+

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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