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510(k) K230253

OPTRELL™ Mapping Catheter with TRUEref™ Technology by Biosense Webster, Inc. — Product Code MTD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 2023
Date Received
January 31, 2023
Clearance Type
Special
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 Biosense Webster, Inc.

  • K252972 — CARTO™ 3 EP Navigation System V8.4 (February 20, 2026)
  • K254085 — CARTO™ 3 EP Navigation System V9.0 with PIU Plus (January 18, 2026)
  • K252302 — CARTO™ 3 EP Navigation System V8.1 (August 22, 2025)
  • K241540 — NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound Catheter (June 28, 2024)
  • K240050 — SOUNDSTAR™ CRYSTAL Ultrasound Catheter (June 12, 2024)
  • K231207 — CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) (September 7, 2023)
  • K231312 — PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webs (July 10, 2023)
  • K231412 — CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-13 (July 10, 2023)
  • K223733 — CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4 (February 16, 2023)
  • K223766 — NUVISION™ NAV Ultrasound Catheter (February 16, 2023)

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)
  • 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)