Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4

K-Number: K223733 · 2023-02-16

ApplicantBiosense Webster, Inc.
Decision Date2023-02-16
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4 is a medical device manufactured by Biosense Webster, Inc.. It received FDA 510(k) clearance on 2023-02-16 under approval number K223733. 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 with CARTOSOUND™ 4D Version 7.4?

CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4 is a medical device that received FDA 510(k) clearance on 2023-02-16. It is manufactured by Biosense Webster, Inc.. The 510(k) number is K223733.

When was CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4 approved by the FDA?

CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4 received FDA 510(k) clearance on 2023-02-16, under approval number K223733.

What company makes CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4?

CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4 is manufactured by Biosense Webster, Inc..

What is the FDA product code for CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4?

The FDA product code for CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4 is DQK.

Related Clinical Trials

NCT03331380 Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System RECRUITING 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 NCT07579832 Quantitative Monitoring of Disability Care Quality for Long-Term Care Facilities 2 NOT_YET_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 →

Related Devices (Code: DQK)

K160218AutoMark ModuleSt Jude Medical K160210EnSite Precision Cardiac Mapping System v2.0St Jude Medical K162643MediGuide Technology SystemSt Jude Medical K162440CardioInsight Cardiac Mapping SystemCardioinsight Technologies, Inc. K160187Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0St Jude Medical K160186EnSite Velocity Surface Electrode KitSt Jude Medical

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.

↑