FDA 510(k)

Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters

N.º K: K233619 · 2024-05-20

Fecha de decisión2024-05-20

Código de productoDXE

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences. It received FDA 510(k) clearance on 2024-05-20 under 510(k) number K233619. The device is classified under product code DXE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

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. The listed applicant is Edwards Lifesciences. The 510(k) number is K233619.

When did Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters receive FDA 510(k) clearance?

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

Who is the listed applicant for Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters?

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

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.

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Dispositivos relacionados (Código: DXE)

K240078Fogarty Thru-Lumen Embolectomy CatheterEdwards Lifesciences, LLC K241330Fogarty Fortis Arterial Embolectomy CatheterEdwards Lifesciences K233820Fogarty Arterial Embolectomy Catheter with Gate ValveEdwards Lifesciences K233819Fogarty Venous Thrombectomy CathetersEdwards Lifesciences, LLC K213771Merlin Aspiration SystemMivi Neurovascular, Inc.K202049Python Catheter/Over-the-Wire Latis Graft Cleaning CatheterApplied Medical Resources Corporation

Fuente oficial

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