FDA 510(k)

MEDRAD® Imaging Bulk Package Transfer Set

N.º K: K173913 · 2018-05-04

Fecha de decisión2018-05-04

Código de productoPQH

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

MEDRAD® Imaging Bulk Package Transfer Set is the device name listed in this FDA 510(k) record. The listed applicant is Bayer U.S., LLC. It received FDA 510(k) clearance on 2018-05-04 under 510(k) number K173913. The device is classified under product code PQH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the MEDRAD® Imaging Bulk Package Transfer Set?

MEDRAD® Imaging Bulk Package Transfer Set is a medical device that received FDA 510(k) clearance on 2018-05-04. The listed applicant is Bayer U.S., LLC. The 510(k) number is K173913.

When did MEDRAD® Imaging Bulk Package Transfer Set receive FDA 510(k) clearance?

MEDRAD® Imaging Bulk Package Transfer Set received FDA 510(k) clearance on 2018-05-04, under 510(k) number K173913.

Who is the listed applicant for MEDRAD® Imaging Bulk Package Transfer Set?

The FDA 510(k) record lists Bayer U.S., LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDRAD® Imaging Bulk Package Transfer Set?

The FDA product code for MEDRAD® Imaging Bulk Package Transfer Set is PQH.

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: PQH)

K253688MEDRAD® Imaging Bulk Package Transfer SpikeBayer Medical Care, Inc.K193010Liebel-Flarsheim IBP Transfer SetLiebel-Flarsheim Company, LLC K200280MEDRAD Imaging Bulk Package Transfer SpikeBayer Medical Care, Inc.K161723ulrich Transfer SetUlrich GmbH & Co. KG

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.