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FDA 510(k)

Prelude IDeal 9F Hydrophilic Sheath Introducer

Número K: K212152 · 2022-01-07

RequerenteMerit Medical Systems
Data da decisão2022-01-07
Código do produtoDYB
Comité consultivoCV
DecisãoSubstantially Equivalent

Resumo do dispositivo

Prelude IDeal 9F Hydrophilic Sheath Introducer is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Systems. It received FDA 510(k) clearance on 2022-01-07 under 510(k) number K212152. 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 Prelude IDeal 9F Hydrophilic Sheath Introducer?

Prelude IDeal 9F Hydrophilic Sheath Introducer is a medical device that received FDA 510(k) clearance on 2022-01-07. The listed applicant is Merit Medical Systems. The 510(k) number is K212152.

When did Prelude IDeal 9F Hydrophilic Sheath Introducer receive FDA 510(k) clearance?

Prelude IDeal 9F Hydrophilic Sheath Introducer received FDA 510(k) clearance on 2022-01-07, under 510(k) number K212152.

Who is the listed applicant for Prelude IDeal 9F Hydrophilic Sheath Introducer?

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

What is the FDA product code for Prelude IDeal 9F Hydrophilic Sheath Introducer?

The FDA product code for Prelude IDeal 9F Hydrophilic Sheath Introducer 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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