FDA 510(k)

Disposable Valve Sets

Número K: K192258 · 2019-12-30

RequerenteZhejiang Chuangxiang Medical Technology Co., Ltd.

Data da decisão2019-12-30

Código do produtoODC

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Disposable Valve Sets is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Chuangxiang Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-12-30 under 510(k) number K192258. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Disposable Valve Sets?

Disposable Valve Sets is a medical device that received FDA 510(k) clearance on 2019-12-30. The listed applicant is Zhejiang Chuangxiang Medical Technology Co., Ltd.. The 510(k) number is K192258.

When did Disposable Valve Sets receive FDA 510(k) clearance?

Disposable Valve Sets received FDA 510(k) clearance on 2019-12-30, under 510(k) number K192258.

Who is the listed applicant for Disposable Valve Sets?

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

What is the FDA product code for Disposable Valve Sets?

The FDA product code for Disposable Valve Sets is ODC.

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 Zhejiang Chuangxiang Medical Technology Co., Ltd. como candidato(a)

K260410Single Use Ureteral Access Sheath K253132Single use stone retrieval balloons K251890Disposable Ureteral Stents K230773Tubo de Irrigação de Endoscopia K231471Tubo de Bote de Ar e Água, Tubo Fonte de CO2 K220063Single Use Cytology Brush

Ver todos os 14 dispositivos →

Dispositivos Relacionados (Código: ODC)

K252933DYNE PORTDyne Medical Group, Inc.K250145Biopsy Port AdapterEndosound, Inc.K252910Orca Air/Water and Suction ValvesBoston Scientific K250949Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)Olympus Medical Systems Corporation K250732Disposable Endoscopy Valve SetYangzhou Fartley Medical Instrument Technology Co., Ltd.K241842Luer-Split MAJ-2092Olympus Medical Systems Corporation

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.