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FDA 510(k)

Reprocessed Supreme Diagnostic Electrophysiology Catheter

K-Number: K182386 · 2019-04-23

ApplicantInnovative Health, LLC
Decision Date2019-04-23
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Reprocessed Supreme Diagnostic Electrophysiology Catheter is a medical device manufactured by Innovative Health, LLC. It received FDA 510(k) clearance on 2019-04-23 under approval number K182386. The device is classified under product code DRF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Reprocessed Supreme Diagnostic Electrophysiology Catheter?

Reprocessed Supreme Diagnostic Electrophysiology Catheter is a medical device that received FDA 510(k) clearance on 2019-04-23. It is manufactured by Innovative Health, LLC. The 510(k) number is K182386.

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

Reprocessed Supreme Diagnostic Electrophysiology Catheter received FDA 510(k) clearance on 2019-04-23, under approval number K182386.

What company makes Reprocessed Supreme Diagnostic Electrophysiology Catheter?

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

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

The FDA product code for Reprocessed Supreme Diagnostic Electrophysiology Catheter is DRF.

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

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Related Devices (Code: DRF)

K160335Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi DSt Jude Medical K161769Reprocessed Supreme Diagnostic Electrophysiology CathetersInnovative Health, LLC K162892Achieve Advance Mapping CatheterMedtronic, Inc. K151139EasyMap MAP CatheterMedfact Engineering GmbH K153139Achieve ST Mapping Catheter, Catheter Connecting CableMedtronic, Inc. K160390Map-it Diagnostic Mapping CathetersAccess Point Technologies Ep, 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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