Home / 510(k) Clearances / K231035

510(k) K231035

FusedCO Algorithm by Edwards Lifesciences, LLC — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 2023
Date Received
April 11, 2023
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 Edwards Lifesciences, LLC

  • K254279 — Edwards eSheath+ introducer set (April 17, 2026)
  • K253186 — HemoSphere Nano Monitor (HSNANO1) (February 24, 2026)
  • K252533 — HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) (December 18, 2025)
  • K253034 — HemoSphere Stream Module (October 21, 2025)
  • K251982 — Edwards MC3 Tricuspid annuloplasty ring (4900) (September 23, 2025)
  • K251688 — Carpentier-Edwards Physio Annuloplasty Ring (4450) (September 17, 2025)
  • K252364 — Edwards eSheath Optima introducer set (August 29, 2025)
  • K243781 — HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); Hem (July 23, 2025)
  • K242518 — Hypertension Prediction Index (HePI) Algorithm (May 15, 2025)
  • K244046 — Edwards eSheath Optima introducer set (March 27, 2025)

Other clearances for product code DQK

  • K253861 — ACORYS MAPPING SYSTEM (April 13, 2026)
  • K253473 — Synchrony (April 1, 2026)
  • 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)