Aviso: Este site agrega dados públicos oficiais da FDA, ClinicalTrials.gov, PubMed e SEC EDGAR apenas para referência geral. Não constitui aconselhamento médico, diagnóstico, recomendação de tratamento ou aconselhamento de investimento.

FDA 510(k)

EasyPass Guidewire

Número K: K153264 · 2016-05-19

RequerenteMedi-Globe Corporation
Data da decisão2016-05-19
Código do produtoOCY
Comité consultivoGU
DecisãoSubstantially Equivalent

Resumo do dispositivo

EasyPass Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Medi-Globe Corporation. It received FDA 510(k) clearance on 2016-05-19 under 510(k) number K153264. The device is classified under product code OCY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the EasyPass Guidewire?

EasyPass Guidewire is a medical device that received FDA 510(k) clearance on 2016-05-19. The listed applicant is Medi-Globe Corporation. The 510(k) number is K153264.

When did EasyPass Guidewire receive FDA 510(k) clearance?

EasyPass Guidewire received FDA 510(k) clearance on 2016-05-19, under 510(k) number K153264.

Who is the listed applicant for EasyPass Guidewire?

The FDA 510(k) record lists Medi-Globe Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EasyPass Guidewire?

The FDA product code for EasyPass Guidewire is OCY.

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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

↑