FDA 510(k)

BioProtect Balloon Implant™ System

Número K: K222972 · 2023-08-25

Data da decisão2023-08-25

Código do produtoOVB

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

BioProtect Balloon Implant™ System is the device name listed in this FDA 510(k) record. The listed applicant is Bioprotect, Ltd.. It received FDA 510(k) clearance on 2023-08-25 under 510(k) number K222972. The device is classified under product code OVB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BioProtect Balloon Implant™ System?

BioProtect Balloon Implant™ System is a medical device that received FDA 510(k) clearance on 2023-08-25. The listed applicant is Bioprotect, Ltd.. The 510(k) number is K222972.

When did BioProtect Balloon Implant™ System receive FDA 510(k) clearance?

BioProtect Balloon Implant™ System received FDA 510(k) clearance on 2023-08-25, under 510(k) number K222972.

Who is the listed applicant for BioProtect Balloon Implant™ System?

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

What is the FDA product code for BioProtect Balloon Implant™ System?

The FDA product code for BioProtect Balloon Implant™ System is OVB.

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: OVB)

K262151SpaceOAR Flex™ SystemBoston Scientific Corporation K260119SpaceOAR Vue System (SV-2101)Boston Scientific Corporation K220641Barrigel Injectable GelPalette Life Sciences K202224SpaceOAR SystemBoston Scientific Corporation K182971SpaceOAR Vue HydrogelAugmenix, Inc.K181465SpaceOAR SystemAugmenix, 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.