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FDA 510(k)

ClosureFast™ Endovenous Radiofrequency Ablation Catheter

K-Number: K223488 · 2023-03-23

ApplicantMedtronic, Inc.
Decision Date2023-03-23
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ClosureFast™ Endovenous Radiofrequency Ablation Catheter is a medical device manufactured by Medtronic, Inc.. It received FDA 510(k) clearance on 2023-03-23 under approval number K223488. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ClosureFast™ Endovenous Radiofrequency Ablation Catheter?

ClosureFast™ Endovenous Radiofrequency Ablation Catheter is a medical device that received FDA 510(k) clearance on 2023-03-23. It is manufactured by Medtronic, Inc.. The 510(k) number is K223488.

When was ClosureFast™ Endovenous Radiofrequency Ablation Catheter approved by the FDA?

ClosureFast™ Endovenous Radiofrequency Ablation Catheter received FDA 510(k) clearance on 2023-03-23, under approval number K223488.

What company makes ClosureFast™ Endovenous Radiofrequency Ablation Catheter?

ClosureFast™ Endovenous Radiofrequency Ablation Catheter is manufactured by Medtronic, Inc..

What is the FDA product code for ClosureFast™ Endovenous Radiofrequency Ablation Catheter?

The FDA product code for ClosureFast™ Endovenous Radiofrequency Ablation Catheter is GEI.

Related Clinical Trials

NCT06510556 Feasibility Study of the FARAFLEX Mapping and PFA System RECRUITING NCT07601763 Pulsed Field Ablation Outcomes With Efficacy and Randomization in Atrial Fibrillation (POWER-AF) RECRUITING NCT06735534 Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System RECRUITING NCT05685134 Epicardial Radiofrequency Catheter Ablation in Patients With Brugada Syndrome COMPLETED NCT07610018 Cerebral Microembolization During Pulmonary Vein Isolation: Comparison of Different Pulsed Field Ablation Systems NOT_YET_RECRUITING NCT07557589 Radiofrequency Treatment for Pilonidal Disease : Clinical Investigation on Safety of Use, Efficacy and Patient Satisfaction at 6 Months RECRUITING

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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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