Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Reprocessed DecaNav Diagnostic Electrophysiology Catheter

K-Number: K180710 · 2018-06-19

ApplicantInnovative Health, LLC
Decision Date2018-06-19
Product CodeNLH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Reprocessed DecaNav Diagnostic Electrophysiology Catheter is a medical device manufactured by Innovative Health, LLC. It received FDA 510(k) clearance on 2018-06-19 under approval number K180710. 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 DecaNav Diagnostic Electrophysiology Catheter?

Reprocessed DecaNav Diagnostic Electrophysiology Catheter is a medical device that received FDA 510(k) clearance on 2018-06-19. It is manufactured by Innovative Health, LLC. The 510(k) number is K180710.

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

Reprocessed DecaNav Diagnostic Electrophysiology Catheter received FDA 510(k) clearance on 2018-06-19, under approval number K180710.

What company makes Reprocessed DecaNav Diagnostic Electrophysiology Catheter?

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

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

The FDA product code for Reprocessed DecaNav 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 NCT05685134 Epicardial Radiofrequency Catheter Ablation in Patients With Brugada Syndrome COMPLETED 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 NCT07210151 Anatomical Navigation for Guided Electrophysiology in AFL and AFib RECRUITING NCT07539701 An Initial Experience With the Disposable Celsio Cryocatheter System for Diagnostic and Interventional Bronchoscopy NOT_YET_RECRUITING

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

View all 48 devices →

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.

↑