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FDA 510(k)

Genie MAX Large Bore Introducer Sheath

N.º K: K253652 · 2026-01-22

SolicitanteCultiv8 1, LLC
Fecha de decisión2026-01-22
Código de productoDYB
Comité asesorCV
DecisiónSubstantially Equivalent

Resumen del dispositivo

Genie MAX Large Bore Introducer Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Cultiv8 1, LLC. It received FDA 510(k) clearance on 2026-01-22 under 510(k) number K253652. 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 Genie MAX Large Bore Introducer Sheath?

Genie MAX Large Bore Introducer Sheath is a medical device that received FDA 510(k) clearance on 2026-01-22. The listed applicant is Cultiv8 1, LLC. The 510(k) number is K253652.

When did Genie MAX Large Bore Introducer Sheath receive FDA 510(k) clearance?

Genie MAX Large Bore Introducer Sheath received FDA 510(k) clearance on 2026-01-22, under 510(k) number K253652.

Who is the listed applicant for Genie MAX Large Bore Introducer Sheath?

The FDA 510(k) record lists Cultiv8 1, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Genie MAX Large Bore Introducer Sheath?

The FDA product code for Genie MAX Large Bore Introducer Sheath is DYB.

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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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