FDA 510(k)

Emerge Monorail PTCA Dilatation Catheter

Número K: K220629 · 2022-03-24

Data da decisão2022-03-24

Código do produtoLOX

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Emerge Monorail PTCA Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific. It received FDA 510(k) clearance on 2022-03-24 under 510(k) number K220629. The device is classified under product code LOX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Emerge Monorail PTCA Dilatation Catheter?

Emerge Monorail PTCA Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2022-03-24. The listed applicant is Boston Scientific. The 510(k) number is K220629.

When did Emerge Monorail PTCA Dilatation Catheter receive FDA 510(k) clearance?

Emerge Monorail PTCA Dilatation Catheter received FDA 510(k) clearance on 2022-03-24, under 510(k) number K220629.

Who is the listed applicant for Emerge Monorail PTCA Dilatation Catheter?

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

What is the FDA product code for Emerge Monorail PTCA Dilatation Catheter?

The FDA product code for Emerge Monorail PTCA Dilatation Catheter is LOX.

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 Boston Scientific como candidato(a)

K262460Rezum System K253692AVVIGO™+ Multi-Modality Guidance System K262406EluPro Antibiotic-Eluting BioEnvelope K260816OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090)K252910Orca Air/Water and Suction Valves K251291Advanix™ Stent Pancreático e Sistema de Entrega Rápida (RX) NaviFlex™ Pancreático e Empurradores

Ver todos os 30 dispositivos →

Dispositivos Relacionados (Código: LOX)

K261428NC Euphora Rapid Exchange Balloon Dilatation CatheterMedtronic Ireland K261759Euphora Rapid Exchange (RX) Balloon Dilatation CatheterMedtronic Ireland K252116Firefighter™ Pro PTCA Balloon CatheterShanghai MicroPort Medical (Group) Co., Ltd.K254022FLASH Flex™ Aorto-Ostial Angioplasty SystemVerge Medical, Inc.K252295RyureiTerumo Corporation K251970Sprinter Legend Rapid Exchange Balloon Dilatation CatheterMedtronic, Ireland

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.