FDA 510(k)

DCwire Micro-guidewire

Número K: K252122 · 2026-03-16

RequerenteShanghai Achieva Medical Suzhou Co., Ltd.

Data da decisão2026-03-16

Código do produtoMOF

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

DCwire Micro-guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Achieva Medical Suzhou Co., Ltd.. It received FDA 510(k) clearance on 2026-03-16 under 510(k) number K252122. The device is classified under product code MOF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the DCwire Micro-guidewire?

DCwire Micro-guidewire is a medical device that received FDA 510(k) clearance on 2026-03-16. The listed applicant is Shanghai Achieva Medical Suzhou Co., Ltd.. The 510(k) number is K252122.

When did DCwire Micro-guidewire receive FDA 510(k) clearance?

DCwire Micro-guidewire received FDA 510(k) clearance on 2026-03-16, under 510(k) number K252122.

Who is the listed applicant for DCwire Micro-guidewire?

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

What is the FDA product code for DCwire Micro-guidewire?

The FDA product code for DCwire Micro-guidewire is MOF.

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

Dispositivos Relacionados (Código: MOF)

K254181Aristotle 65 MacrowireScientia Vascular K26075135 Helix GuidewirePiraeus Medical, Inc.K262424Willow 12 GuidewireArbor Endovascular, LLC K260223Aristotle Mini GuidewireScientia Vascular, Inc.K254006Drivewire 35 GuidewireRapid Medical Ltd.K253579Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 GuidewireScientia Vascular, Inc.

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.