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FDA 510(k)

V•Stick™ Vascular Access Set

N.º K: K253741 · 2025-12-15

SolicitanteArgon Medical Devices, Inc.
Fecha de decisión2025-12-15
Código de productoDYB
Comité asesorCV
DecisiónSubstantially Equivalent

Resumen del dispositivo

V•Stick™ Vascular Access Set 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 2025-12-15 under 510(k) number K253741. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the V•Stick™ Vascular Access Set?

V•Stick™ Vascular Access Set is a medical device that received FDA 510(k) clearance on 2025-12-15. The listed applicant is Argon Medical Devices, Inc.. The 510(k) number is K253741.

When did V•Stick™ Vascular Access Set receive FDA 510(k) clearance?

V•Stick™ Vascular Access Set received FDA 510(k) clearance on 2025-12-15, under 510(k) number K253741.

Who is the listed applicant for V•Stick™ Vascular Access Set?

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 V•Stick™ Vascular Access Set?

The FDA product code for V•Stick™ Vascular Access Set is DYB.

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Otros registros que enlistan a Argon Medical Devices, Inc. como solicitante

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K252795ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863212130 / ZeniCore Automatic Biopsy Device 12ga x 13cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214100 / ZeniCore Automatic Biopsy Device 14ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214130 / ZeniCore Automatic Biopsy Device 14ga x 13cm with CoaxialK260028CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece, CLEANER™ Vac Aspiration CanisterK251318VariFuse Adjustable Infusion CatheterK242612Option ELITE Vena Cava Filter System (352506070E 352506100E)K241145TLAB® Transvenous Liver Biopsy System (TF-18C)K233909Cleaner™ Plus 18F Thrombectomy System - Cleaner™ Plus 18F Aspiration Catheter, Cleaner™ Plus 18F Handpiece with Maceration Wire, Cleaner™ Plus 18F Aspiration Canister

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Dispositivos relacionados (Código: DYB)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K253526NAMIC Dilator and SheathMedline Industries, LPK261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLCK261242SimplGuidePendracareK261950Health Line Tearaway IntroducerHealth Line International CorporationK261492FieldFlex Steerable SheathCenterPoint Systems, LLCK260606Echo Large Bore Introducer SheathEcho Medical, LLC

Fuente oficial

Ver en la base de datos de la FDA →

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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