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FDA 510(k)

Achieve Advance Mapping Catheter

K-Number: K162892 · 2016-11-15

ApplicantMedtronic, Inc.
Decision Date2016-11-15
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Achieve Advance Mapping Catheter is a medical device manufactured by Medtronic, Inc.. It received FDA 510(k) clearance on 2016-11-15 under approval number K162892. 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 Achieve Advance Mapping Catheter?

Achieve Advance Mapping Catheter is a medical device that received FDA 510(k) clearance on 2016-11-15. It is manufactured by Medtronic, Inc.. The 510(k) number is K162892.

When was Achieve Advance Mapping Catheter approved by the FDA?

Achieve Advance Mapping Catheter received FDA 510(k) clearance on 2016-11-15, under approval number K162892.

What company makes Achieve Advance Mapping Catheter?

Achieve Advance Mapping Catheter is manufactured by Medtronic, Inc..

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

The FDA product code for Achieve Advance Mapping Catheter is DRF.

Related Clinical Trials

NCT01254474 Evaluation of Depolarization and Repolarisation Activity During Cardiac Arrhythmia Using a Novel Monophasic Action Potential Catheter COMPLETED 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 NCT03053141 RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY) RECRUITING NCT05225935 Computed Tomography-Guided Catheter Ablation for Ventricular Tachycardia COMPLETED NCT07308847 Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360) RECRUITING

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Related Devices (Code: DRF)

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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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