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510(k) K210766

AcQMap 3D Imaging and Mapping Catheter, Model 900009 by Acutus Medical, Inc. — Product Code MTD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 2022
Date Received
March 15, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intracardiac Mapping, High-Density Array
Device Class
Class II
Regulation Number
870.1220
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)
  • 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)

Other clearances for product code MTD

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  • K233433 — Sphere-9Dx Diagnostic Catheter (AFR-00009) (August 7, 2024)
  • K241372 — Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™ (July 9, 2024)
  • K231312 — PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webs (July 10, 2023)
  • K223666 — Ablacath™ Mapping Catheter (March 17, 2023)
  • K230253 — OPTRELL™ Mapping Catheter with TRUEref™ Technology (March 2, 2023)
  • K211438 — OPTRELL Mapping Catheter with TRUEref Technology (March 18, 2022)
  • K201806 — Reprocessed PentaRay Nav eco High-Density Mapping Catheter (June 23, 2021)
  • K201341 — AcQMap 3D Imaging and Mapping Catheter (September 15, 2020)
  • K200212 — Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled (September 3, 2020)