VX1+
K-Number: K223516 · 2023-01-21
ApplicantVolta Medical
Decision Date2023-01-21
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
VX1+ is a medical device manufactured by Volta Medical. It received FDA 510(k) clearance on 2023-01-21 under approval number K223516. 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 2023-01-21. It is manufactured by Volta Medical. The 510(k) number is K223516.
When was VX1+ approved by the FDA?
VX1+ received FDA 510(k) clearance on 2023-01-21, under approval number K223516.
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
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
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.