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FDA 510(k)

Fogarty Occlusion Catheter

K-Number: K211610 · 2022-02-14

ApplicantEdwards Lifesciences, LLC
Decision Date2022-02-14
Product CodeMJN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Fogarty Occlusion Catheter is a medical device manufactured by Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2022-02-14 under approval number K211610. The device is classified under product code MJN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fogarty Occlusion Catheter?

Fogarty Occlusion Catheter is a medical device that received FDA 510(k) clearance on 2022-02-14. It is manufactured by Edwards Lifesciences, LLC. The 510(k) number is K211610.

When was Fogarty Occlusion Catheter approved by the FDA?

Fogarty Occlusion Catheter received FDA 510(k) clearance on 2022-02-14, under approval number K211610.

What company makes Fogarty Occlusion Catheter?

Fogarty Occlusion Catheter is manufactured by Edwards Lifesciences, LLC.

What is the FDA product code for Fogarty Occlusion Catheter?

The FDA product code for Fogarty Occlusion Catheter is MJN.

Related Clinical Trials

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Related Devices (Code: MJN)

K160598REBOA Balloon CatheterNuMED, Inc. K153530Bridge Occlusion BalloonSpectranetics, Inc. K152833Pruitt F3-S Polyurethane Carotid ShuntLeMaitre Vascular, Inc. K172790ER-REBOA CatheterPrytime Medical Devices, Inc. K170411ER-REBOA CatheterPrytime Medical Devices, Inc. K160067RenovoCathRenovorx, 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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