FDA 510(k)

CystoSure Plus Catheter

Número K: K181346 · 2018-08-06

Data da decisão2018-08-06

Código do produtoEZL

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

CystoSure Plus Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Emmy Medical, LLC. It received FDA 510(k) clearance on 2018-08-06 under 510(k) number K181346. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CystoSure Plus Catheter?

CystoSure Plus Catheter is a medical device that received FDA 510(k) clearance on 2018-08-06. The listed applicant is Emmy Medical, LLC. The 510(k) number is K181346.

When did CystoSure Plus Catheter receive FDA 510(k) clearance?

CystoSure Plus Catheter received FDA 510(k) clearance on 2018-08-06, under 510(k) number K181346.

Who is the listed applicant for CystoSure Plus Catheter?

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

What is the FDA product code for CystoSure Plus Catheter?

The FDA product code for CystoSure Plus Catheter is EZL.

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: EZL)

K260756TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)Sentinel Medical Technologies,K262056Rusch Latex Gold Foley CatheterTeleflex Medical Sdn. Bhd.K252537Rusch SoftSimplastic Foley CathetersTeleflex Medical Sdn. Bhd.K243011Silicone Urethral Catheter (Silicone Urethral Catheter)Guangdong Ecan Medical Co., Ltd.K241424InnoCare Specialty Foley CatheterInnocare Urologics, LLC K232469Rüsch Latex Gold Foley CatheterTeleflexmedical, 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.