FDA 510(k)

VX1

K-Number: K201298 · 2020-09-16

Decision Date2020-09-16

Product CodeDQK

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

VX1 is a medical device manufactured by Volta Medical. It received FDA 510(k) clearance on 2020-09-16 under approval 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. It is manufactured by Volta Medical. The 510(k) number is K201298.

When was VX1 approved by the FDA?

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

What company makes VX1?

VX1 is manufactured by Volta Medical.

What is the FDA product code for VX1?

The FDA product code for VX1 is DQK.

Other Devices by Volta Medical

K232616Volta AF-Xplorer K223516VX1+ K251518Volta AF-Xplorer II K243812Volta AF-Xplorer

Related Devices (Code: DQK)

K160218AutoMark ModuleSt Jude Medical K160210EnSite Precision Cardiac Mapping System v2.0St Jude Medical K162643MediGuide Technology SystemSt Jude Medical K162440CardioInsight Cardiac Mapping SystemCardioinsight Technologies, Inc. K160187Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0St Jude Medical K160186EnSite Velocity Surface Electrode KitSt Jude Medical

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.