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FDA 510(k)

Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters

K-Number: K233619 · 2024-05-20

ApplicantEdwards Lifesciences
Decision Date2024-05-20
Product CodeDXE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters is a medical device manufactured by Edwards Lifesciences. It received FDA 510(k) clearance on 2024-05-20 under approval number K233619. 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 Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters?

Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters is a medical device that received FDA 510(k) clearance on 2024-05-20. It is manufactured by Edwards Lifesciences. The 510(k) number is K233619.

When was Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters approved by the FDA?

Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters received FDA 510(k) clearance on 2024-05-20, under approval number K233619.

What company makes Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters?

Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters is manufactured by Edwards Lifesciences.

What is the FDA product code for Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters?

The FDA product code for Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters is DXE.

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.

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