FDA 510(k)

BD Centro Vena Acute Central Line (7 French Dual Lumen)

N.º K: K200266 · 2020-04-07

SolicitanteBard Access Systems, Inc. (Bard Has Joined Bd)

Fecha de decisión2020-04-07

Código de productoFOZ

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

BD Centro Vena Acute Central Line (7 French Dual Lumen) is the device name listed in this FDA 510(k) record. The listed applicant is Bard Access Systems, Inc. (Bard Has Joined Bd). It received FDA 510(k) clearance on 2020-04-07 under 510(k) number K200266. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the BD Centro Vena Acute Central Line (7 French Dual Lumen)?

BD Centro Vena Acute Central Line (7 French Dual Lumen) is a medical device that received FDA 510(k) clearance on 2020-04-07. The listed applicant is Bard Access Systems, Inc. (Bard Has Joined Bd). The 510(k) number is K200266.

When did BD Centro Vena Acute Central Line (7 French Dual Lumen) receive FDA 510(k) clearance?

BD Centro Vena Acute Central Line (7 French Dual Lumen) received FDA 510(k) clearance on 2020-04-07, under 510(k) number K200266.

Who is the listed applicant for BD Centro Vena Acute Central Line (7 French Dual Lumen)?

The FDA 510(k) record lists Bard Access Systems, Inc. (Bard Has Joined Bd) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD Centro Vena Acute Central Line (7 French Dual Lumen)?

The FDA product code for BD Centro Vena Acute Central Line (7 French Dual Lumen) is FOZ.

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 Bard Access Systems, Inc. (Bard Has Joined Bd) como solicitante

K190855BD Acute Central Line

Dispositivos relacionados (Código: FOZ)

K260432Ruby Intravascular CatheterVenocare, Inc.K260165Unimpregnated Central Venous CatheterSpectrum Vascular K261041ClearSafe Closed SystemMedSource Labs, LLC K260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLC K253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc.K252137BD Insyte™ IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.

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.