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510(k) K223666

Ablacath™ Mapping Catheter by Ablacon, Inc. — Product Code MTD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 2023
Date Received
December 7, 2022
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 Ablacon, Inc.

  • K230008 — Ablamap® System (June 8, 2023)
  • K203084 — Ablamap Software (August 31, 2021)

Other clearances for product code MTD

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  • 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)
  • 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)
  • K201341 — AcQMap 3D Imaging and Mapping Catheter (September 15, 2020)
  • K200212 — Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled (September 3, 2020)