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FDA 510(k)

Option ELITE Vena Cava Filter System (352506070E 352506100E)

N.º K: K242612 · 2024-09-10

SolicitanteArgon Medical Devices, Inc.
Fecha de decisión2024-09-10
Código de productoDTK
Comité asesorCV
DecisiónSubstantially Equivalent

Resumen del dispositivo

Option ELITE Vena Cava Filter System (352506070E 352506100E) is the device name listed in this FDA 510(k) record. The listed applicant is Argon Medical Devices, Inc.. It received FDA 510(k) clearance on 2024-09-10 under 510(k) number K242612. The device is classified under product code DTK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Option ELITE Vena Cava Filter System (352506070E 352506100E)?

Option ELITE Vena Cava Filter System (352506070E 352506100E) is a medical device that received FDA 510(k) clearance on 2024-09-10. The listed applicant is Argon Medical Devices, Inc.. The 510(k) number is K242612.

When did Option ELITE Vena Cava Filter System (352506070E 352506100E) receive FDA 510(k) clearance?

Option ELITE Vena Cava Filter System (352506070E 352506100E) received FDA 510(k) clearance on 2024-09-10, under 510(k) number K242612.

Who is the listed applicant for Option ELITE Vena Cava Filter System (352506070E 352506100E)?

The FDA 510(k) record lists Argon Medical Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Option ELITE Vena Cava Filter System (352506070E 352506100E)?

The FDA product code for Option ELITE Vena Cava Filter System (352506070E 352506100E) is DTK.

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Dispositivos relacionados (Código: DTK)

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K240578VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter SystemB.Braun Medical, Inc.K241507ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK)Aln S.A.R.L.K240257Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery KitBdK233680Celect Platinum Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-CELECT-PT); Celect Platinum Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-CELECT-PT); Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach (IGTCFS-65-1-UNI-CELECT-PT); Günther Tulip Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-TULIP); Günther Tulip Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-TULIP); Günther Tulip Vena Cava FilterWilliam Cook Europe ApsK211874Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Jugular Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein ApproachWilliam Cook Europe ApsK211875Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filte Set for Jugular Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein ApproachWilliam Cook Europe Aps

Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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