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510(k) K251518

Volta AF-Xplorer II by Volta Medical — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2025
Date Received
May 16, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Programmable
Device Class
Class II
Regulation Number
870.1425
Review Panel
CV
Submission Type

Other clearances by Volta Medical

  • K243812 — Volta AF-Xplorer (May 9, 2025)
  • K232616 — Volta AF-Xplorer (September 27, 2023)
  • K223516 — VX1+ (January 21, 2023)
  • K201298 — VX1 (September 16, 2020)

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  • K253733 — STAR Apollo™ Mapping System (December 19, 2025)
  • K252533 — HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) (December 18, 2025)
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