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510(k) K254089

IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter, 125cm (C01251); IOPS Viewpoint Double Curve Catheter, 75cm (C00752); IOPS Viewpoint Double Curve Catheter, 125cm (C02152); IOPS Guidewire 2 (ATW-2); IOPS Fiducial Tracking Pad (T02111); IOPS Guidewire Handle (H01035) by Centerline Biomedical, Inc. — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 2026
Date Received
December 19, 2025
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 Centerline Biomedical, Inc.

  • K243842 — Intra-Operative Positioning System (IOPS®) (March 6, 2025)
  • K242133 — Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operat (October 11, 2024)
  • K241243 — Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); I (July 24, 2024)
  • K230309 — Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (S (June 21, 2023)
  • K190106 — Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Cathete (June 24, 2019)

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)
  • 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)
  • K252429 — Vektor Computational ECG Mapping System (vMap®) (December 4, 2025)