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FDA 510(k)

Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled

K-Number: K200212 · 2020-09-03

ApplicantInnovative Health, LLC
Decision Date2020-09-03
Product CodeMTD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled is a medical device manufactured by Innovative Health, LLC. It received FDA 510(k) clearance on 2020-09-03 under approval number K200212. 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 Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled?

Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled is a medical device that received FDA 510(k) clearance on 2020-09-03. It is manufactured by Innovative Health, LLC. The 510(k) number is K200212.

When was Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled approved by the FDA?

Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled received FDA 510(k) clearance on 2020-09-03, under approval number K200212.

What company makes Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled?

Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled is manufactured by Innovative Health, LLC.

What is the FDA product code for Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled?

The FDA product code for Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled is MTD.

Related Clinical Trials

NCT01254474 Evaluation of Depolarization and Repolarisation Activity During Cardiac Arrhythmia Using a Novel Monophasic Action Potential Catheter COMPLETED NCT07475091 Standardizing Swallow Pressure Measurements NOT_YET_RECRUITING 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

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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. K201750Pentaray Nav eco High-Density Mapping CatheterBiosense Webster, 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.

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