FDA 510(k)

EZ-IO Intraosseous Vascular Access System

N.º K: K202492 · 2021-03-22

Fecha de decisión2021-03-22

Código de productoFMI

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

EZ-IO Intraosseous Vascular Access System is the device name listed in this FDA 510(k) record. The listed applicant is Teleflex Medical. It received FDA 510(k) clearance on 2021-03-22 under 510(k) number K202492. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the EZ-IO Intraosseous Vascular Access System?

EZ-IO Intraosseous Vascular Access System is a medical device that received FDA 510(k) clearance on 2021-03-22. The listed applicant is Teleflex Medical. The 510(k) number is K202492.

When did EZ-IO Intraosseous Vascular Access System receive FDA 510(k) clearance?

EZ-IO Intraosseous Vascular Access System received FDA 510(k) clearance on 2021-03-22, under 510(k) number K202492.

Who is the listed applicant for EZ-IO Intraosseous Vascular Access System?

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

What is the FDA product code for EZ-IO Intraosseous Vascular Access System?

The FDA product code for EZ-IO Intraosseous Vascular Access System is FMI.

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 Teleflex Medical como solicitante

K261418Liquick X-treme, Liquick X-treme Plus K251054Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips K242495LMA Fastrach ETT SU K243553QuikClot Control+ Hemostatic Device K241784Hilo de Acero Nitinol Arrow®K233713Pilling Tracheostomy Tubes

Ver todos los 21 dispositivos →

Dispositivos relacionados (Código: FMI)

K261266MOWANA™ Auto DuoPENTAMASTER MEDIQ SDN BHD K261719Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)Hh Global Technology, Inc.K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd.K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., 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.