FDA 510(k)

OPTRELL™ Mapping Catheter with TRUEref™ Technology

K-Number: K230253 · 2023-03-02

Decision Date2023-03-02

Product CodeMTD

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

OPTRELL™ Mapping Catheter with TRUEref™ Technology 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 2023-03-02 under 510(k) number K230253. The device is classified under product code MTD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTRELL™ Mapping Catheter with TRUEref™ Technology?

OPTRELL™ Mapping Catheter with TRUEref™ Technology is a medical device that received FDA 510(k) clearance on 2023-03-02. The listed applicant is Biosense Webster, Inc.. The 510(k) number is K230253.

When did OPTRELL™ Mapping Catheter with TRUEref™ Technology receive FDA 510(k) clearance?

OPTRELL™ Mapping Catheter with TRUEref™ Technology received FDA 510(k) clearance on 2023-03-02, under 510(k) number K230253.

Who is the listed applicant for OPTRELL™ Mapping Catheter with TRUEref™ Technology?

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 OPTRELL™ Mapping Catheter with TRUEref™ Technology?

The FDA product code for OPTRELL™ Mapping Catheter with TRUEref™ Technology is MTD.

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 NCT07227532A 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

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: MTD)

K261012OptiMap Catheter - 60mm (OPTI-CATH2-60)Cortex, Inc.K253205OptiMap Catheter - 50mm (OPTI-CATH2-50)Cortex, Inc.K233433Sphere-9Dx Diagnostic Catheter (AFR-00009)Medtronic K241372Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™ABBOTT MEDICAL K231312PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto IDBiosense Webster, Inc.K223666Ablacath™ Mapping CatheterAblacon, Inc.

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.