FDA 510(k)

Sistema de Endoprótesis AXIOS y Sistema de Entrega, Sistema de Entrega Mejorado con Electrocauterio AXIOS

N.º K: K181905 · 2019-03-25

SolicitanteBoston Scientific Corporation

Fecha de decisión2019-03-25

Código de productoPCU

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2019-03-25 under 510(k) number K181905. The device is classified under product code PCU. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System?

AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System is a medical device that received FDA 510(k) clearance on 2019-03-25. The listed applicant is Boston Scientific Corporation. The 510(k) number is K181905.

When did AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System receive FDA 510(k) clearance?

AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System received FDA 510(k) clearance on 2019-03-25, under 510(k) number K181905.

Who is the listed applicant for AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System?

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

What is the FDA product code for AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System?

The FDA product code for AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System is PCU.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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

Otros registros que enlistan a Boston Scientific Corporation como solicitante

K262151SpaceOAR Flex™ System K261153LithoVue Elite Digital Flexible Ureteroscope System K261915Navigator™ Flex Ureteral Access Sheath Set K262165FARADRIVE™ Steerable Sheath (M004PF21M402)K262462TheraSphere 360™ Y-90 Management Platform K261488OBSIDIO Conformable Embolic

Ver todos los 167 dispositivos →

Dispositivos relacionados (Código: PCU)

K252648Niti-S SPAXUS StentTaewoong Medical Co., Ltd.K220112Sistema de Entrega Mejorado con Electrocauterio AXIOSBoston Scientific Corporation K203132Sistema de Entrega Mejorado con Electrocauterio AXIOSBoston Scientific Corporation K192043Sistema de Entrega Mejorado con Electrocauterio AXIOSBoston Scientific Corporation K163272Sistema de Entrega Mejorado con Electrocauterio AXIOSBoston Scientific Corporation

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.