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FDA 510(k)

Fogarty Fortis Arterial Embolectomy Catheter

K-Number: K241330 · 2024-07-02

ApplicantEdwards Lifesciences
Decision Date2024-07-02
Product CodeDXE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Fogarty Fortis Arterial Embolectomy Catheter is a medical device manufactured by Edwards Lifesciences. It received FDA 510(k) clearance on 2024-07-02 under approval number K241330. The device is classified under product code DXE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fogarty Fortis Arterial Embolectomy Catheter?

Fogarty Fortis Arterial Embolectomy Catheter is a medical device that received FDA 510(k) clearance on 2024-07-02. It is manufactured by Edwards Lifesciences. The 510(k) number is K241330.

When was Fogarty Fortis Arterial Embolectomy Catheter approved by the FDA?

Fogarty Fortis Arterial Embolectomy Catheter received FDA 510(k) clearance on 2024-07-02, under approval number K241330.

What company makes Fogarty Fortis Arterial Embolectomy Catheter?

Fogarty Fortis Arterial Embolectomy Catheter is manufactured by Edwards Lifesciences.

What is the FDA product code for Fogarty Fortis Arterial Embolectomy Catheter?

The FDA product code for Fogarty Fortis Arterial Embolectomy Catheter is DXE.

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Related Devices (Code: DXE)

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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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