FDA 510(k)

LassoStar Circular Mapping Catheter

K-Number: K193632 · 2020-06-30

Decision Date2020-06-30

Product CodeDRF

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

LassoStar Circular Mapping Catheter 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 2020-06-30 under 510(k) number K193632. The device is classified under product code DRF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LassoStar Circular Mapping Catheter?

LassoStar Circular Mapping Catheter is a medical device that received FDA 510(k) clearance on 2020-06-30. The listed applicant is Biosense Webster, Inc.. The 510(k) number is K193632.

When did LassoStar Circular Mapping Catheter receive FDA 510(k) clearance?

LassoStar Circular Mapping Catheter received FDA 510(k) clearance on 2020-06-30, under 510(k) number K193632.

Who is the listed applicant for LassoStar Circular Mapping Catheter?

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 LassoStar Circular Mapping Catheter?

The FDA product code for LassoStar Circular Mapping Catheter is DRF.

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.

NCT04750798An Observational Post-marketing Study Using Commercially Approved Biosense Webster (BWI) Medical Devices for the Treatment of Participants With Cardiac ArrhythmiasRECRUITING NCT07116525A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping CatheterRECRUITING NCT02565069Identification for the Treatment of Complex ArrhythmiasCOMPLETED NCT05565599An Early Feasibility Study Evaluating the Safety and Efficacy of the Laminar Left Atrial Appendage Closure System in Subjects With Non-Valvular Atrial FibrillationACTIVE_NOT_RECRUITING NCT06168942A Pivotal Investigational Device Exemption Study on Laminar Left Atrial Appendage EliminationSUSPENDED NCT06455098A Study of Assessment on Safety and Effectiveness of BWI Pulsed Field Ablation With OMNYPULSE Catheter for the Treatment of Paroxysmal Atrial Fibrillation (PAF)ACTIVE_NOT_RECRUITING

Other records listing Biosense Webster, Inc. as applicant

PMA P030031catheter, percutaneous, cardiac ablation, for treatment of atrial flutter PMA P240006Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation PMA P210027Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation K252972CARTO™ 3 EP Navigation System V8.4 K254085CARTO™ 3 EP Navigation System V9.0 with PIU Plus PMA P990071Cardiac ablation percutaneous catheter

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Related Devices (Code: DRF)

K252794Vision-MR™ Diagnostic CatheterImricor Medical Systems, Inc.K250590MAGiC Sweep™ EP Mapping CatheterStereotaxis, Inc.K250310VIKING™ Fixed Curve Diagnostic CatheterBoston Scientific Corporation PMA P990025CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDINGBiosense Webster, Inc.K240366EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic XT™ Unidirectional Steerable Diagnostic CatheterBoston Scientific Corporation K233900Nordica PV Cryo Mapping CatheterSynaptic Medical Corporation

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.