FDA 510(k)

Health Line Tearaway Introducer

Número K: K261950 · 2026-06-22

RequerenteHealth Line International Corporation

Data da decisão2026-06-22

Código do produtoDYB

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Health Line Tearaway Introducer is the device name listed in this FDA 510(k) record. The listed applicant is Health Line International Corporation. It received FDA 510(k) clearance on 2026-06-22 under 510(k) number K261950. 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 Health Line Tearaway Introducer?

Health Line Tearaway Introducer is a medical device that received FDA 510(k) clearance on 2026-06-22. The listed applicant is Health Line International Corporation. The 510(k) number is K261950.

When did Health Line Tearaway Introducer receive FDA 510(k) clearance?

Health Line Tearaway Introducer received FDA 510(k) clearance on 2026-06-22, under 510(k) number K261950.

Who is the listed applicant for Health Line Tearaway Introducer?

The FDA 510(k) record lists Health Line International Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Health Line Tearaway Introducer?

The FDA product code for Health Line Tearaway Introducer is DYB.

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Outros registros que listam Health Line International Corporation 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 K261492FieldFlex Steerable SheathCenterPoint Systems, LLC K260606Echo Large Bore Introducer SheathEcho Medical, LLC K254248Introducer Sheath SetCardiocycle Medical(Suzhou) Co., Ltd.

Fonte oficial

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