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FDA 510(k)

Reprocessed Response Diagnostic Electrophysiology Catheter

K-Number: K182488 · 2019-02-22

ApplicantInnovative Health, LLC
Decision Date2019-02-22
Product CodeNLH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Reprocessed Response Diagnostic Electrophysiology Catheter is a medical device manufactured by Innovative Health, LLC. It received FDA 510(k) clearance on 2019-02-22 under approval number K182488. 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 Response Diagnostic Electrophysiology Catheter?

Reprocessed Response Diagnostic Electrophysiology Catheter is a medical device that received FDA 510(k) clearance on 2019-02-22. It is manufactured by Innovative Health, LLC. The 510(k) number is K182488.

When was Reprocessed Response Diagnostic Electrophysiology Catheter approved by the FDA?

Reprocessed Response Diagnostic Electrophysiology Catheter received FDA 510(k) clearance on 2019-02-22, under approval number K182488.

What company makes Reprocessed Response Diagnostic Electrophysiology Catheter?

Reprocessed Response Diagnostic Electrophysiology Catheter is manufactured by Innovative Health, LLC.

What is the FDA product code for Reprocessed Response Diagnostic Electrophysiology Catheter?

The FDA product code for Reprocessed Response Diagnostic 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 NCT05857852 Low-Intensity Focused Ultrasound for Cocaine Use Disorder COMPLETED NCT05685134 Epicardial Radiofrequency Catheter Ablation in Patients With Brugada Syndrome COMPLETED NCT07385508 Neurorehabilitation in Patients With Disorders of Consciousness: Multidimensional Ambispective Study on the Impact of Single and Combined Approaches RECRUITING NCT07595666 Comparison of NeuroEXPLORER PET/CT Versus Standard-of-care PET/CT of the Head and Neck Region. ENROLLING_BY_INVITATION NCT07471308 P-wave Duration and Local Potential as Predictors of AF Recurrence Following Pulmonary Vein Isolation ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 40747091 A decade of review in global regulation and research of artificial intelligence medical devices (2015-2025). Frontiers in medicine (2025) PMID: 40246728 [Analysis of the Core Principles and Key Design and Development Control Factors of Two Typical Point-of-Care Testing Technologies]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025) PMID: 39900769 Regulatory Perspectives for Gene Expression-Based Diagnostic Devices. Methods in molecular biology (Clifton, N.J.) (2025)

Other Devices by Innovative Health, LLC

K162251Reprocessed Viking Diagnostic Electrophysiology Catheters K161827Reprocessed Response Diagnostic Electrophysiology Catheters K161769Reprocessed Supreme Diagnostic Electrophysiology Catheters K160421Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry Optima Steerable Diagnostic EP Catheter K161393Reprocessed Orbiter ST Steerable Diagnostic EP Catheter K161464Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters

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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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