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FDA 510(k)

CARTO™ 3 EP Navigation System V9.0 with PIU Plus

K-Number: K254085 · 2026-01-18

ApplicantBiosense Webster, Inc.
Decision Date2026-01-18
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARTO™ 3 EP Navigation System V9.0 with PIU Plus is a medical device manufactured by Biosense Webster, Inc.. It received FDA 510(k) clearance on 2026-01-18 under approval number K254085. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARTO™ 3 EP Navigation System V9.0 with PIU Plus?

CARTO™ 3 EP Navigation System V9.0 with PIU Plus is a medical device that received FDA 510(k) clearance on 2026-01-18. It is manufactured by Biosense Webster, Inc.. The 510(k) number is K254085.

When was CARTO™ 3 EP Navigation System V9.0 with PIU Plus approved by the FDA?

CARTO™ 3 EP Navigation System V9.0 with PIU Plus received FDA 510(k) clearance on 2026-01-18, under approval number K254085.

What company makes CARTO™ 3 EP Navigation System V9.0 with PIU Plus?

CARTO™ 3 EP Navigation System V9.0 with PIU Plus is manufactured by Biosense Webster, Inc..

What is the FDA product code for CARTO™ 3 EP Navigation System V9.0 with PIU Plus?

The FDA product code for CARTO™ 3 EP Navigation System V9.0 with PIU Plus is DQK.

Related Clinical Trials

NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT07173309 Evaluation of Eye Gaze Sharing in the Operating Room RECRUITING NCT07174479 Eye Gaze Guidance Evaluation in Phantoms COMPLETED NCT07572253 A Study of Using CARTO SOUND™ FAM to Guide Pulsed Field Ablation for Atrial Fibrillation NOT_YET_RECRUITING NCT06631638 EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) RECRUITING NCT07271238 Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures RECRUITING

Related PubMed Literature

PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

Other Devices by Biosense Webster, Inc.

K170997CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath K170600CARTO 3 EP Navigation System, Version 6.0 and Accessories K173978CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER Module K173977CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module K180238CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT K191660CARTO 3 EP Navigation System, Version 7.1 and Accessories

View all 33 devices →

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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