Home / 510(k) Clearances / K223516

510(k) K223516

VX1+ by Volta Medical — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 2023
Date Received
November 22, 2022
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

  • K251518 — Volta AF-Xplorer II (September 12, 2025)
  • K243812 — Volta AF-Xplorer (May 9, 2025)
  • K232616 — Volta AF-Xplorer (September 27, 2023)
  • K201298 — VX1 (September 16, 2020)

Other clearances for product code DQK

  • K253186 — HemoSphere Nano Monitor (HSNANO1) (February 24, 2026)
  • K252972 — CARTO™ 3 EP Navigation System V8.4 (February 20, 2026)
  • K254089 — IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751 (February 17, 2026)
  • K251591 — Holter ECG and ABP system (HolterABP) (February 9, 2026)
  • K251218 — SafeBeat Rx App (February 6, 2026)
  • K252164 — NorthStar™ Mapping System (January 28, 2026)
  • K254085 — CARTO™ 3 EP Navigation System V9.0 with PIU Plus (January 18, 2026)
  • K253733 — STAR Apollo™ Mapping System (December 19, 2025)
  • K252533 — HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) (December 18, 2025)
  • K253141 — DeepRhythmAI (December 11, 2025)