FDA 510(k)

Introducer Sheath Set

Número K: K254248 · 2026-04-23

RequerenteCardiocycle Medical(Suzhou) Co., Ltd.

Data da decisão2026-04-23

Código do produtoDYB

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Introducer Sheath Set is the device name listed in this FDA 510(k) record. The listed applicant is Cardiocycle Medical(Suzhou) Co., Ltd.. It received FDA 510(k) clearance on 2026-04-23 under 510(k) number K254248. 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 Set?

Introducer Sheath Set is a medical device that received FDA 510(k) clearance on 2026-04-23. The listed applicant is Cardiocycle Medical(Suzhou) Co., Ltd.. The 510(k) number is K254248.

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

Introducer Sheath Set received FDA 510(k) clearance on 2026-04-23, under 510(k) number K254248.

Who is the listed applicant for Introducer Sheath Set?

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

What is the FDA product code for Introducer Sheath Set?

The FDA product code for Introducer Sheath Set is DYB.

Ensaios clínicos relacionados

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Outros registros que listam Cardiocycle Medical(Suzhou) Co., Ltd. como candidato(a)

K251838Introducer Sheath Set

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

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.