FDA 510(k)

CryoTreQ

Número K: K202038 · 2020-12-30

Data da decisão2020-12-30

Código do produtoHPS

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

CryoTreQ is the device name listed in this FDA 510(k) record. The listed applicant is VitreQ BV. It received FDA 510(k) clearance on 2020-12-30 under 510(k) number K202038. The device is classified under product code HPS. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CryoTreQ?

CryoTreQ is a medical device that received FDA 510(k) clearance on 2020-12-30. The listed applicant is VitreQ BV. The 510(k) number is K202038.

When did CryoTreQ receive FDA 510(k) clearance?

CryoTreQ received FDA 510(k) clearance on 2020-12-30, under 510(k) number K202038.

Who is the listed applicant for CryoTreQ?

The FDA 510(k) record lists VitreQ BV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CryoTreQ?

The FDA product code for CryoTreQ is HPS.

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 VitreQ BV como candidato(a)

K182646Vitreq disposable laser probes, light fibers and Chandelier

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.