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510(k) K212345

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2021
Date Received
July 28, 2021
Clearance Type
Special
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)
  • K231091 — AcQMap High Resolution Imaging and Mapping System (July 10, 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)
  • K210680 — AcQMap High Resolution Imaging and Mapping System (August 5, 2021)
  • K211100 — AcQGuide MAX Steerable Sheath (May 14, 2021)

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