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FDA 510(k)

CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)

K-Number: K231207 · 2023-09-07

ApplicantBiosense Webster, Inc.
Decision Date2023-09-07
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) is the device name listed in this FDA 510(k) record. The listed applicant is Biosense Webster, Inc.. It received FDA 510(k) clearance on 2023-09-07 under 510(k) number K231207. 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 Software V8.0 (FG-5400-00, FG-5400-00U)?

CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) is a medical device that received FDA 510(k) clearance on 2023-09-07. The listed applicant is Biosense Webster, Inc.. The 510(k) number is K231207.

When did CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) receive FDA 510(k) clearance?

CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) received FDA 510(k) clearance on 2023-09-07, under 510(k) number K231207.

Who is the listed applicant for CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)?

The FDA 510(k) record lists Biosense Webster, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)?

The FDA product code for CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) is DQK.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT02565069Identification for the Treatment of Complex ArrhythmiasCOMPLETEDNCT04750798An Observational Post-marketing Study Using Commercially Approved Biosense Webster (BWI) Medical Devices for the Treatment of Participants With Cardiac ArrhythmiasRECRUITINGNCT05565599An Early Feasibility Study Evaluating the Safety and Efficacy of the Laminar Left Atrial Appendage Closure System in Subjects With Non-Valvular Atrial FibrillationACTIVE_NOT_RECRUITINGNCT06168942A Pivotal Investigational Device Exemption Study on Laminar Left Atrial Appendage EliminationSUSPENDEDNCT07116525A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping CatheterRECRUITINGNCT07227532A Study Assessing Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With VARIPULSE Catheter SystemRECRUITING

Other records listing Biosense Webster, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P030031catheter, percutaneous, cardiac ablation, for treatment of atrial flutterPMA P240006Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible ElectroporationPMA P210027Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillationK252972CARTO™ 3 EP Navigation System V8.4K254085CARTO™ 3 EP Navigation System V9.0 with PIU PlusPMA P990071Cardiac ablation percutaneous catheter

View all 35 devices →

Related Devices (Code: DQK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLCK253463ILR ECG Analyzer (IM007)Implicity, Inc.K261119NorthStar Mapping System (MAP01 or MAP01-01)Imricor Medical Systems, Inc.K253088OneStim-DUO Cardiac Stimulator (MP5003-4CO)Micropace Pty, Ltd.

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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