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FDA 510(k)

Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Catheter

K-Number: K191170 · 2019-10-30

ApplicantInnovative Health, LLC
Decision Date2019-10-30
Product CodeNLH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Catheter is a medical device manufactured by Innovative Health, LLC. It received FDA 510(k) clearance on 2019-10-30 under approval number K191170. 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 Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Catheter?

Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Catheter is a medical device that received FDA 510(k) clearance on 2019-10-30. It is manufactured by Innovative Health, LLC. The 510(k) number is K191170.

When was Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Catheter approved by the FDA?

Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Catheter received FDA 510(k) clearance on 2019-10-30, under approval number K191170.

What company makes Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Catheter?

Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Catheter is manufactured by Innovative Health, LLC.

What is the FDA product code for Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Catheter?

The FDA product code for Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Catheter is NLH.

Related Clinical Trials

NCT01254474 Evaluation of Depolarization and Repolarisation Activity During Cardiac Arrhythmia Using a Novel Monophasic Action Potential Catheter COMPLETED NCT05685134 Epicardial Radiofrequency Catheter Ablation in Patients With Brugada Syndrome COMPLETED NCT07210151 Anatomical Navigation for Guided Electrophysiology in AFL and AFib RECRUITING NCT05971693 A Study For Treatment of Paroxysmal Atrial Fibrillation (PAF) With the OMNYPULSE Catheter and the TRUPULSE Generator COMPLETED

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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