FDA 510(k)

Drakon™ and Sequre® Microcatheters

N.º K: K231293 · 2023-06-01

SolicitanteAccurate Medical Therapeutics

Fecha de decisión2023-06-01

Código de productoDQO

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Drakon™ and Sequre® Microcatheters is the device name listed in this FDA 510(k) record. The listed applicant is Accurate Medical Therapeutics. It received FDA 510(k) clearance on 2023-06-01 under 510(k) number K231293. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Drakon™ and Sequre® Microcatheters?

Drakon™ and Sequre® Microcatheters is a medical device that received FDA 510(k) clearance on 2023-06-01. The listed applicant is Accurate Medical Therapeutics. The 510(k) number is K231293.

When did Drakon™ and Sequre® Microcatheters receive FDA 510(k) clearance?

Drakon™ and Sequre® Microcatheters received FDA 510(k) clearance on 2023-06-01, under 510(k) number K231293.

Who is the listed applicant for Drakon™ and Sequre® Microcatheters?

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

What is the FDA product code for Drakon™ and Sequre® Microcatheters?

The FDA product code for Drakon™ and Sequre® Microcatheters is DQO.

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: DQO)

K261455Conjunto/Plato de Monitoreo de Presión ArterialSpectrum Vascular K252702Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602NBioptimal International Pte. , Ltd.K254278Conjunto/Plato de Monitoreo de Presión ArterialSpectrum Vascular K250751DualView CatheterTerumo Corporation K242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLC K242420pNOVUS 21 MicrocatheterPhenox, 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.