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)

ClearGuard HD Antimicrobial Barrier Cap

Número K: K180111 · 2018-05-25

RequerentePursuit Vascular, Inc.
Data da decisão2018-05-25
Código do produtoPEH
Comité consultivoGU
DecisãoSubstantially Equivalent

Resumo do dispositivo

ClearGuard HD Antimicrobial Barrier Cap is the device name listed in this FDA 510(k) record. The listed applicant is Pursuit Vascular, Inc.. It received FDA 510(k) clearance on 2018-05-25 under 510(k) number K180111. The device is classified under product code PEH. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ClearGuard HD Antimicrobial Barrier Cap?

ClearGuard HD Antimicrobial Barrier Cap is a medical device that received FDA 510(k) clearance on 2018-05-25. The listed applicant is Pursuit Vascular, Inc.. The 510(k) number is K180111.

When did ClearGuard HD Antimicrobial Barrier Cap receive FDA 510(k) clearance?

ClearGuard HD Antimicrobial Barrier Cap received FDA 510(k) clearance on 2018-05-25, under 510(k) number K180111.

Who is the listed applicant for ClearGuard HD Antimicrobial Barrier Cap?

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

What is the FDA product code for ClearGuard HD Antimicrobial Barrier Cap?

The FDA product code for ClearGuard HD Antimicrobial Barrier Cap is PEH.

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.

↑