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FDA 510(k)

Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter

K-Number: K191880 · 2019-12-11

ApplicantInnovative Health, LLC
Decision Date2019-12-11
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter is a medical device manufactured by Innovative Health, LLC. It received FDA 510(k) clearance on 2019-12-11 under approval number K191880. 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 Achieve Advance Mapping Diagnostic Electrophysiology Catheter?

Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter is a medical device that received FDA 510(k) clearance on 2019-12-11. It is manufactured by Innovative Health, LLC. The 510(k) number is K191880.

When was Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter approved by the FDA?

Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter received FDA 510(k) clearance on 2019-12-11, under approval number K191880.

What company makes Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter?

Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter is manufactured by Innovative Health, LLC.

What is the FDA product code for Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter?

The FDA product code for Reprocessed Achieve Advance Mapping 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 NCT07137455 EDEN Intracardiac Electrogram Recording and Classifying System ENROLLING_BY_INVITATION NCT06510556 Feasibility Study of the FARAFLEX Mapping and PFA System RECRUITING NCT07611903 HFNC Versus Microstream Advance Nasal Cannula for Oxygenation During ERCP NOT_YET_RECRUITING NCT05685134 Epicardial Radiofrequency Catheter Ablation in Patients With Brugada Syndrome COMPLETED NCT03053141 RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY) RECRUITING

Other Devices by Innovative Health, LLC

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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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