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510(k) K231091

AcQMap High Resolution Imaging and Mapping System by Acutus Medical, Inc. — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 2023
Date Received
April 17, 2023
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 Acutus Medical, Inc.

  • K233691 — FlexCath Cross Transseptal Solution (December 17, 2023)
  • K230606 — AcQMap® High Resolution Imaging and Mapping System (May 2, 2023)
  • K222209 — AcQMap High Resolution Imaging and Mapping System (October 17, 2022)
  • K220784 — AcQMap High Resolution Imaging and Mapping System (July 1, 2022)
  • K210766 — AcQMap 3D Imaging and Mapping Catheter, Model 900009 (June 21, 2022)
  • K221044 — AcQGuide® VUE Steerable Sheath (May 5, 2022)
  • K220047 — AcQCross Qx Integrated Transseptal Dilator/Needle (February 8, 2022)
  • K212345 — AcQMap High Resolution Imaging and Mapping System (August 27, 2021)
  • K210680 — AcQMap High Resolution Imaging and Mapping System (August 5, 2021)
  • K211100 — AcQGuide MAX Steerable Sheath (May 14, 2021)

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