FDA 510(k)

WIRION Embolic Protection System

N.º K: K210282 · 2021-03-03

Fecha de decisión2021-03-03

Código de productoNTE

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

WIRION Embolic Protection System is the device name listed in this FDA 510(k) record. The listed applicant is Cardiovascular Systems, Inc.. It received FDA 510(k) clearance on 2021-03-03 under 510(k) number K210282. The device is classified under product code NTE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the WIRION Embolic Protection System?

WIRION Embolic Protection System is a medical device that received FDA 510(k) clearance on 2021-03-03. The listed applicant is Cardiovascular Systems, Inc.. The 510(k) number is K210282.

When did WIRION Embolic Protection System receive FDA 510(k) clearance?

WIRION Embolic Protection System received FDA 510(k) clearance on 2021-03-03, under 510(k) number K210282.

Who is the listed applicant for WIRION Embolic Protection System?

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

What is the FDA product code for WIRION Embolic Protection System?

The FDA product code for WIRION Embolic Protection System is NTE.

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 Cardiovascular Systems, Inc. como solicitante

K220109DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System K212725ViperCross Support Catheters K210586Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system K211240ViperCross Support Catheters K211251ViperCath XC Peripheral Exchange Catheter K203008DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System

Ver todos los 13 dispositivos →

Dispositivos relacionados (Código: NTE)

K222694EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)MicroVention, Inc.K230402ENROUTE® Transcarotid Neuroprotection SystemSilk Road Medical K220654GUIDA DE CAPTURA DE EMBOLOS ANGIOGUARD XP, GUIDA DE CAPTURA DE EMBOLOS ANGIOGUARD RXCordis Corporation K200198WIRIONCardiovascular Systems, Inc.K191173Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery WiresAbbott Vascular K180023WIRIONGardia Medical , Ltd.

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.