FDA 510(k)

Borvo EVAC System (Ergo); Borvo EVAC System (Classic)

Número K: K241458 · 2024-08-20

Data da decisão2024-08-20

Código do produtoJXG

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Borvo EVAC System (Ergo); Borvo EVAC System (Classic) is the device name listed in this FDA 510(k) record. The listed applicant is Borvo Medical, Inc.. It received FDA 510(k) clearance on 2024-08-20 under 510(k) number K241458. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Borvo EVAC System (Ergo); Borvo EVAC System (Classic)?

Borvo EVAC System (Ergo); Borvo EVAC System (Classic) is a medical device that received FDA 510(k) clearance on 2024-08-20. The listed applicant is Borvo Medical, Inc.. The 510(k) number is K241458.

When did Borvo EVAC System (Ergo); Borvo EVAC System (Classic) receive FDA 510(k) clearance?

Borvo EVAC System (Ergo); Borvo EVAC System (Classic) received FDA 510(k) clearance on 2024-08-20, under 510(k) number K241458.

Who is the listed applicant for Borvo EVAC System (Ergo); Borvo EVAC System (Classic)?

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

What is the FDA product code for Borvo EVAC System (Ergo); Borvo EVAC System (Classic)?

The FDA product code for Borvo EVAC System (Ergo); Borvo EVAC System (Classic) is JXG.

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: JXG)

K261004Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684)Integra Lifesciences Production Corporation K251598IntellidropBrainspace, Inc.K250636Sophy Mini Monopressure Valve (SM1)Sophysa K252514EVAC-MRIPhasor Health, LLC K243531Codman Libertís Shunt Catheter with Bactiseal and Endexo TechnologyIntegra Lifesciences Production Corporation K243552Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libertís™ 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762)Integra Lifesciences Production Corporation

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.