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510(k) K201341

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2020
Date Received
May 20, 2020
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)
  • 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)

Other clearances for product code MTD

  • K253205 — OptiMap Catheter - 50mm (OPTI-CATH2-50) (March 13, 2026)
  • 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)
  • K210766 — AcQMap 3D Imaging and Mapping Catheter, Model 900009 (June 21, 2022)
  • K211438 — OPTRELL Mapping Catheter with TRUEref Technology (March 18, 2022)
  • K201806 — Reprocessed PentaRay Nav eco High-Density Mapping Catheter (June 23, 2021)
  • K200212 — Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled (September 3, 2020)