FDA 510(k)

Impella CP Introducer

Número K: K192769 · 2019-11-18

Data da decisão2019-11-18

Código do produtoDYB

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Impella CP Introducer is the device name listed in this FDA 510(k) record. The listed applicant is Abiomed, Inc.. It received FDA 510(k) clearance on 2019-11-18 under 510(k) number K192769. 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 Impella CP Introducer?

Impella CP Introducer is a medical device that received FDA 510(k) clearance on 2019-11-18. The listed applicant is Abiomed, Inc.. The 510(k) number is K192769.

When did Impella CP Introducer receive FDA 510(k) clearance?

Impella CP Introducer received FDA 510(k) clearance on 2019-11-18, under 510(k) number K192769.

Who is the listed applicant for Impella CP Introducer?

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

What is the FDA product code for Impella CP Introducer?

The FDA product code for Impella CP Introducer is DYB.

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Outros registros que listam Abiomed, Inc. como candidato(a)

K25276614Fr Low Profile Introducer Kit K241708Kit de Introduzidor 14Fr Baixo Profilo da Abiomed K221294preCARDIA Occlusion System K223161OXY-1 System K222113Conjunto de Introduzidor 14Fr Baixo Profilo da Abiomed K202330Impella XR Sheath Set

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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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