FDA 510(k)

Radifocus Glidewire Advantage Track

N.º K: K163004 · 2017-01-30

SolicitanteAshitaka Factory of Terumo Coporation

Fecha de decisión2017-01-30

Código de productoDQX

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Radifocus Glidewire Advantage Track is the device name listed in this FDA 510(k) record. The listed applicant is Ashitaka Factory of Terumo Coporation. It received FDA 510(k) clearance on 2017-01-30 under 510(k) number K163004. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Radifocus Glidewire Advantage Track?

Radifocus Glidewire Advantage Track is a medical device that received FDA 510(k) clearance on 2017-01-30. The listed applicant is Ashitaka Factory of Terumo Coporation. The 510(k) number is K163004.

When did Radifocus Glidewire Advantage Track receive FDA 510(k) clearance?

Radifocus Glidewire Advantage Track received FDA 510(k) clearance on 2017-01-30, under 510(k) number K163004.

Who is the listed applicant for Radifocus Glidewire Advantage Track?

The FDA 510(k) record lists Ashitaka Factory of Terumo Coporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Radifocus Glidewire Advantage Track?

The FDA product code for Radifocus Glidewire Advantage Track is DQX.

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

Dispositivos relacionados (Código: DQX)

K253146Hyperdrive 35 GuidewireRapid-Medical , Ltd.K261281CROSSLEAD Standard 035 and CROSSLEAD Stiff 035Filmecc Co., Ltd.K253667Accoat Guide WireSp Medical A/S K261640Merit MAK Nitinol/Gold-Tungsten Guide WireMerit Medical Ireland , Ltd.K254137InQwire Amplatz Guide WireMerit Medical Ireland, Ltd.K260544FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40FMD Co., 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.