FDA 510(k)

ClosureFast™ Endovenous Radiofrequency Ablation Catheter

K-Number: K223488 · 2023-03-23

Decision Date2023-03-23

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ClosureFast™ Endovenous Radiofrequency Ablation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2023-03-23 under 510(k) 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. The listed applicant is Medtronic, Inc.. The 510(k) number is K223488.

When did ClosureFast™ Endovenous Radiofrequency Ablation Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for ClosureFast™ Endovenous Radiofrequency Ablation Catheter?

The FDA 510(k) record lists Medtronic, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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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.