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 Advanced Focus Mapping (AFM)

K-Number: K221112 · 2022-08-17

ApplicantBiosense Webster, Inc.
Decision Date2022-08-17
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM) is a medical device manufactured by Biosense Webster, Inc.. It received FDA 510(k) clearance on 2022-08-17 under approval number K221112. 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 Advanced Focus Mapping (AFM)?

CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM) is a medical device that received FDA 510(k) clearance on 2022-08-17. It is manufactured by Biosense Webster, Inc.. The 510(k) number is K221112.

When was CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM) approved by the FDA?

CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM) received FDA 510(k) clearance on 2022-08-17, under approval number K221112.

What company makes CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM)?

CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM) is manufactured by Biosense Webster, Inc..

What is the FDA product code for CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM)?

The FDA product code for CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM) is DQK.

Related Clinical Trials

NCT01254474 Evaluation of Depolarization and Repolarisation Activity During Cardiac Arrhythmia Using a Novel Monophasic Action Potential Catheter COMPLETED NCT07137455 EDEN Intracardiac Electrogram Recording and Classifying System ENROLLING_BY_INVITATION NCT03280862 DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS COMPLETED NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT06510556 Feasibility Study of the FARAFLEX Mapping and PFA System RECRUITING NCT06385392 Continuous Wearable Monitor for the Detection and Release of Freezing of Gait. COMPLETED

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.

↑