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FDA 510(k)

Micropuncture Introducer Sets; Micropuncture Pedal Access Sets

Número K: K240589 · 2024-03-25

RequerenteCook Medical
Data da decisão2024-03-25
Código do produtoDYB
Comité consultivoCV
DecisãoSubstantially Equivalent

Resumo do dispositivo

Micropuncture Introducer Sets; Micropuncture Pedal Access Sets is the device name listed in this FDA 510(k) record. The listed applicant is Cook Medical. It received FDA 510(k) clearance on 2024-03-25 under 510(k) number K240589. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Micropuncture Introducer Sets; Micropuncture Pedal Access Sets?

Micropuncture Introducer Sets; Micropuncture Pedal Access Sets is a medical device that received FDA 510(k) clearance on 2024-03-25. The listed applicant is Cook Medical. The 510(k) number is K240589.

When did Micropuncture Introducer Sets; Micropuncture Pedal Access Sets receive FDA 510(k) clearance?

Micropuncture Introducer Sets; Micropuncture Pedal Access Sets received FDA 510(k) clearance on 2024-03-25, under 510(k) number K240589.

Who is the listed applicant for Micropuncture Introducer Sets; Micropuncture Pedal Access Sets?

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

What is the FDA product code for Micropuncture Introducer Sets; Micropuncture Pedal Access Sets?

The FDA product code for Micropuncture Introducer Sets; Micropuncture Pedal Access Sets is DYB.

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Dispositivos Relacionados (Código: DYB)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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

Fonte oficial

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