FDA 510(k)

TAV System

Número K: K152664 · 2016-12-02

Data da decisão2016-12-02

Código do produtoONZ

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

TAV System is the device name listed in this FDA 510(k) record. The listed applicant is New Aera, Inc.. It received FDA 510(k) clearance on 2016-12-02 under 510(k) number K152664. The device is classified under product code ONZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the TAV System?

TAV System is a medical device that received FDA 510(k) clearance on 2016-12-02. The listed applicant is New Aera, Inc.. The 510(k) number is K152664.

When did TAV System receive FDA 510(k) clearance?

TAV System received FDA 510(k) clearance on 2016-12-02, under 510(k) number K152664.

Who is the listed applicant for TAV System?

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

What is the FDA product code for TAV System?

The FDA product code for TAV System is ONZ.

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

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.