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FDA 510(k)

Pentaray Nav eco High-Density Mapping Catheter

K-Number: K201750 · 2020-08-06

ApplicantBiosense Webster, Inc.
Decision Date2020-08-06
Product CodeMTD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Pentaray Nav eco High-Density Mapping Catheter is a medical device manufactured by Biosense Webster, Inc.. It received FDA 510(k) clearance on 2020-08-06 under approval number K201750. 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 Pentaray Nav eco High-Density Mapping Catheter?

Pentaray Nav eco High-Density Mapping Catheter is a medical device that received FDA 510(k) clearance on 2020-08-06. It is manufactured by Biosense Webster, Inc.. The 510(k) number is K201750.

When was Pentaray Nav eco High-Density Mapping Catheter approved by the FDA?

Pentaray Nav eco High-Density Mapping Catheter received FDA 510(k) clearance on 2020-08-06, under approval number K201750.

What company makes Pentaray Nav eco High-Density Mapping Catheter?

Pentaray Nav eco High-Density Mapping Catheter is manufactured by Biosense Webster, Inc..

What is the FDA product code for Pentaray Nav eco High-Density Mapping Catheter?

The FDA product code for Pentaray Nav eco High-Density Mapping Catheter 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 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 NCT06808217 A Registry on the FARAVIEW Technology of the OPAL HDx Mapping System When Used With the FARAWAVE NAV Ablation Catheter in the Treatment of Atrial Fibrillation ACTIVE_NOT_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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