FDA 510(k)

MEDRAD® Imaging Bulk Package Transfer Set

Номер K: K173913 · 2018-05-04

Дата решения2018-05-04

Код продуктаPQH

Консультативный комитетHO

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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

Связанные устройства (Код: 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

Официальный источник

Посмотреть в базе данных FDA →

Данные получены из открытого API FDA. Для получения наиболее актуальной и авторитетной информации всегда обращайтесь к официальным записям.