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FDA 510(k)

Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter

K-Number: K181458 · 2018-10-27

ApplicantInnovative Health, LLC
Decision Date2018-10-27
Product CodeNLH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter is a medical device manufactured by Innovative Health, LLC. It received FDA 510(k) clearance on 2018-10-27 under approval number K181458. The device is classified under product code NLH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter?

Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter is a medical device that received FDA 510(k) clearance on 2018-10-27. It is manufactured by Innovative Health, LLC. The 510(k) number is K181458.

When was Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter approved by the FDA?

Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter received FDA 510(k) clearance on 2018-10-27, under approval number K181458.

What company makes Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter?

Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter is manufactured by Innovative Health, LLC.

What is the FDA product code for Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter?

The FDA product code for Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter is NLH.

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

Other Devices by Innovative Health, LLC

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Related Devices (Code: NLH)

K162251Reprocessed Viking Diagnostic Electrophysiology CathetersInnovative Health, LLC K161827Reprocessed Response Diagnostic Electrophysiology CathetersInnovative Health, LLC K160421Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry Optima Steerable Diagnostic EP CatheterInnovative Health, LLC K161393Reprocessed Orbiter ST Steerable Diagnostic EP CatheterInnovative Health, LLC K161464Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology CathetersInnovative Health, LLC K153006Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) CatheterSterilmed, 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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