FDA 510(k)

Superpipe Angiographic Catheter

N.º K: K193647 · 2020-07-29

SolicitanteSuzhou Hengrui Disheng Medical Co., Ltd.

Fecha de decisión2020-07-29

Código de productoDQO

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Superpipe Angiographic Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Hengrui Disheng Medical Co., Ltd.. It received FDA 510(k) clearance on 2020-07-29 under 510(k) number K193647. 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 Superpipe Angiographic Catheter?

Superpipe Angiographic Catheter is a medical device that received FDA 510(k) clearance on 2020-07-29. The listed applicant is Suzhou Hengrui Disheng Medical Co., Ltd.. The 510(k) number is K193647.

When did Superpipe Angiographic Catheter receive FDA 510(k) clearance?

Superpipe Angiographic Catheter received FDA 510(k) clearance on 2020-07-29, under 510(k) number K193647.

Who is the listed applicant for Superpipe Angiographic Catheter?

The FDA 510(k) record lists Suzhou Hengrui Disheng Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Superpipe Angiographic Catheter?

The FDA product code for Superpipe Angiographic Catheter 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

Otros registros que enlistan a Suzhou Hengrui Disheng Medical Co., Ltd. como solicitante

K193653Hydrophilic Coating Guide Wire K171665Microcatheter and guide-wire system

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.