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FDA 510(k)

Fogarty Arterial Embolectomy Catheter with Gate Valve

K-Number: K233820 · 2024-05-22

ApplicantEdwards Lifesciences
Decision Date2024-05-22
Product CodeDXE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Fogarty Arterial Embolectomy Catheter with Gate Valve is a medical device manufactured by Edwards Lifesciences. It received FDA 510(k) clearance on 2024-05-22 under approval number K233820. 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 Arterial Embolectomy Catheter with Gate Valve?

Fogarty Arterial Embolectomy Catheter with Gate Valve is a medical device that received FDA 510(k) clearance on 2024-05-22. It is manufactured by Edwards Lifesciences. The 510(k) number is K233820.

When was Fogarty Arterial Embolectomy Catheter with Gate Valve approved by the FDA?

Fogarty Arterial Embolectomy Catheter with Gate Valve received FDA 510(k) clearance on 2024-05-22, under approval number K233820.

What company makes Fogarty Arterial Embolectomy Catheter with Gate Valve?

Fogarty Arterial Embolectomy Catheter with Gate Valve is manufactured by Edwards Lifesciences.

What is the FDA product code for Fogarty Arterial Embolectomy Catheter with Gate Valve?

The FDA product code for Fogarty Arterial Embolectomy Catheter with Gate Valve 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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