Home / 510(k) Clearances / K200212

510(k) K200212

Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled by Innovative Health, LLC — Product Code MTD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 2020
Date Received
January 28, 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 Innovative Health, LLC

  • K250305 — Reprocessed Agilis NxT Steerable Introducer (January 7, 2026)
  • K231015 — Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters (July 1, 2024)
  • K233825 — Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter (June 7, 2024)
  • K232037 — Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding (April 4, 2024)
  • K230376 — Reprocessed Agilis NxT Steerable Introducer (August 7, 2023)
  • K213584 — Reprocessed NRG Transseptal Needle (April 4, 2023)
  • K221854 — Reprocesses Umbilical Cable (August 6, 2022)
  • K210655 — Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter (May 25, 2022)
  • K212165 — Reprocessed Carto Vizigo Bi-Directional Guiding Sheath (March 10, 2022)
  • K212776 — Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled (December 20, 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)
  • K201341 — AcQMap 3D Imaging and Mapping Catheter (September 15, 2020)