FDA 510(k)

Introducer Sheath Kits

Número K: K222184 · 2023-02-21

RequerenteBeijing Demax Medical Technology Co.,Ltd

Data da decisão2023-02-21

Código do produtoDYB

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Introducer Sheath Kits is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Demax Medical Technology Co.,Ltd. It received FDA 510(k) clearance on 2023-02-21 under 510(k) number K222184. 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 Introducer Sheath Kits?

Introducer Sheath Kits is a medical device that received FDA 510(k) clearance on 2023-02-21. The listed applicant is Beijing Demax Medical Technology Co.,Ltd. The 510(k) number is K222184.

When did Introducer Sheath Kits receive FDA 510(k) clearance?

Introducer Sheath Kits received FDA 510(k) clearance on 2023-02-21, under 510(k) number K222184.

Who is the listed applicant for Introducer Sheath Kits?

The FDA 510(k) record lists Beijing Demax Medical Technology Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Introducer Sheath Kits?

The FDA product code for Introducer Sheath Kits is DYB.

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Outros registros que listam Beijing Demax Medical Technology Co.,Ltd como candidato(a)

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Dispositivos Relacionados (Código: DYB)

K253526NAMIC Dilator and SheathMedline Industries, LP K261529Micropuncture 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, LLC K261242SimplGuidePendracare K261950Health Line Tearaway IntroducerHealth Line International Corporation K261492FieldFlex Steerable SheathCenterPoint Systems, LLC K260606Echo Large Bore Introducer SheathEcho Medical, LLC

Fonte oficial

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