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510(k) K221112

CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM) by Biosense Webster, Inc. — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 2022
Date Received
April 15, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Programmable
Device Class
Class II
Regulation Number
870.1425
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)
  • K230253 — OPTRELL™ Mapping Catheter with TRUEref™ Technology (March 2, 2023)
  • K223733 — CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4 (February 16, 2023)

Other clearances for product code DQK

  • K253186 — HemoSphere Nano Monitor (HSNANO1) (February 24, 2026)
  • K252972 — CARTO™ 3 EP Navigation System V8.4 (February 20, 2026)
  • K254089 — IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751 (February 17, 2026)
  • K251591 — Holter ECG and ABP system (HolterABP) (February 9, 2026)
  • K251218 — SafeBeat Rx App (February 6, 2026)
  • K252164 — NorthStar™ Mapping System (January 28, 2026)
  • K254085 — CARTO™ 3 EP Navigation System V9.0 with PIU Plus (January 18, 2026)
  • K253733 — STAR Apollo™ Mapping System (December 19, 2025)
  • K252533 — HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) (December 18, 2025)
  • K253141 — DeepRhythmAI (December 11, 2025)