FDA 510(k)

Venture 0.014 Catheter

Número K: K182570 · 2019-03-13

Data da decisão2019-03-13

Código do produtoDQY

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Venture 0.014 Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Vascular Solutions, LLC. It received FDA 510(k) clearance on 2019-03-13 under 510(k) number K182570. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Venture 0.014 Catheter?

Venture 0.014 Catheter is a medical device that received FDA 510(k) clearance on 2019-03-13. The listed applicant is Vascular Solutions, LLC. The 510(k) number is K182570.

When did Venture 0.014 Catheter receive FDA 510(k) clearance?

Venture 0.014 Catheter received FDA 510(k) clearance on 2019-03-13, under 510(k) number K182570.

Who is the listed applicant for Venture 0.014 Catheter?

The FDA 510(k) record lists Vascular Solutions, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Venture 0.014 Catheter?

The FDA product code for Venture 0.014 Catheter is DQY.

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 Vascular Solutions, LLC como candidato(a)

Ver todos os 11 dispositivos →

Dispositivos Relacionados (Código: DQY)

K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc.K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLC K262240SSPC NXT Delivery CatheterCenterPoint Systems, LLC K261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC K261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CateterAbbott

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.