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FDA 510(k)

PerQseal Introducers

Número K: K252309 · 2025-10-23

RequerenteVivasure Medical Limited
Data da decisão2025-10-23
Código do produtoDYB
Comité consultivoCV
DecisãoSubstantially Equivalent

Resumo do dispositivo

PerQseal Introducers is the device name listed in this FDA 510(k) record. The listed applicant is Vivasure Medical Limited. It received FDA 510(k) clearance on 2025-10-23 under 510(k) number K252309. 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 PerQseal Introducers?

PerQseal Introducers is a medical device that received FDA 510(k) clearance on 2025-10-23. The listed applicant is Vivasure Medical Limited. The 510(k) number is K252309.

When did PerQseal Introducers receive FDA 510(k) clearance?

PerQseal Introducers received FDA 510(k) clearance on 2025-10-23, under 510(k) number K252309.

Who is the listed applicant for PerQseal Introducers?

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

What is the FDA product code for PerQseal Introducers?

The FDA product code for PerQseal Introducers 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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