FDA 510(k)

PathBuilder Transseptal Guiding Introducer

Número K: K212626 · 2022-03-23

RequerenteShanghai Microport EP Medtech Co., Ltd.

Data da decisão2022-03-23

Código do produtoDYB

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

PathBuilder Transseptal Guiding Introducer is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Microport EP Medtech Co., Ltd.. It received FDA 510(k) clearance on 2022-03-23 under 510(k) number K212626. 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 PathBuilder Transseptal Guiding Introducer?

PathBuilder Transseptal Guiding Introducer is a medical device that received FDA 510(k) clearance on 2022-03-23. The listed applicant is Shanghai Microport EP Medtech Co., Ltd.. The 510(k) number is K212626.

When did PathBuilder Transseptal Guiding Introducer receive FDA 510(k) clearance?

PathBuilder Transseptal Guiding Introducer received FDA 510(k) clearance on 2022-03-23, under 510(k) number K212626.

Who is the listed applicant for PathBuilder Transseptal Guiding Introducer?

The FDA 510(k) record lists Shanghai Microport EP Medtech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PathBuilder Transseptal Guiding Introducer?

The FDA product code for PathBuilder Transseptal Guiding Introducer is DYB.

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Outros registros que listam Shanghai Microport EP Medtech Co., Ltd. como candidato(a)

K210313EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter K212625PathBuilder Transseptal Needle K211530PathBuilder Steerable Introducer

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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