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FDA 510(k)

Carto Octaray Mapping Catheter with Trueref Technology

K-Number: K193237 · 2020-07-31

ApplicantBiosense Webster, Inc.
Decision Date2020-07-31
Product CodeMTD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Carto Octaray Mapping Catheter with Trueref Technology is a medical device manufactured by Biosense Webster, Inc.. It received FDA 510(k) clearance on 2020-07-31 under approval number K193237. 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 Carto Octaray Mapping Catheter with Trueref Technology?

Carto Octaray Mapping Catheter with Trueref Technology is a medical device that received FDA 510(k) clearance on 2020-07-31. It is manufactured by Biosense Webster, Inc.. The 510(k) number is K193237.

When was Carto Octaray Mapping Catheter with Trueref Technology approved by the FDA?

Carto Octaray Mapping Catheter with Trueref Technology received FDA 510(k) clearance on 2020-07-31, under approval number K193237.

What company makes Carto Octaray Mapping Catheter with Trueref Technology?

Carto Octaray Mapping Catheter with Trueref Technology is manufactured by Biosense Webster, Inc..

What is the FDA product code for Carto Octaray Mapping Catheter with Trueref Technology?

The FDA product code for Carto Octaray Mapping Catheter with Trueref Technology is MTD.

Related Clinical Trials

NCT01254474 Evaluation of Depolarization and Repolarisation Activity During Cardiac Arrhythmia Using a Novel Monophasic Action Potential Catheter COMPLETED NCT06510556 Feasibility Study of the FARAFLEX Mapping and PFA System RECRUITING NCT03053141 RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY) RECRUITING NCT06939478 AI Powered Mapping Technology for Identifying Arrhythmias COMPLETED NCT05225935 Computed Tomography-Guided Catheter Ablation for Ventricular Tachycardia COMPLETED NCT07308847 Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360) RECRUITING

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

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Related Devices (Code: MTD)

K153093FIRMap CatheterAbbott Electrophysiology K170819AcQMap 3D Imaging and Mapping CatheterAcutus Medical, Inc. K163709FIRMap CatheterAbbott Electrophysiology K172393Advisor HD Grid Mapping Catheter, Sensor EnabledSt. Jude Medical, Inc. K201341AcQMap 3D Imaging and Mapping CatheterAcutus Medical, Inc. K200212Reprocessed Advisor HD Grid Mapping Catheter, Sensor EnabledInnovative Health, LLC

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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