FDA 510(k)

BD Intraosseous Infusion System

Номер K: K203193 · 2021-03-04

ЗаявительBard Access Systems, Inc(Bas)[Wholly-Owned Subsidiary of Bd]

Дата решения2021-03-04

Код продуктаMHC

Консультативный комитетHO

РешениеSubstantially Equivalent

Описание устройства

BD Intraosseous Infusion System is the device name listed in this FDA 510(k) record. The listed applicant is Bard Access Systems, Inc(Bas)[Wholly-Owned Subsidiary of Bd]. It received FDA 510(k) clearance on 2021-03-04 under 510(k) number K203193. The device is classified under product code MHC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the BD Intraosseous Infusion System?

BD Intraosseous Infusion System is a medical device that received FDA 510(k) clearance on 2021-03-04. The listed applicant is Bard Access Systems, Inc(Bas)[Wholly-Owned Subsidiary of Bd]. The 510(k) number is K203193.

When did BD Intraosseous Infusion System receive FDA 510(k) clearance?

BD Intraosseous Infusion System received FDA 510(k) clearance on 2021-03-04, under 510(k) number K203193.

Who is the listed applicant for BD Intraosseous Infusion System?

The FDA 510(k) record lists Bard Access Systems, Inc(Bas)[Wholly-Owned Subsidiary of Bd] as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD Intraosseous Infusion System?

The FDA product code for BD Intraosseous Infusion System is MHC.

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: MHC)

K223198BD Intraosseous Vascular Access System EMS Powered Driver (D001003)Bard Access Systems

Официальный источник

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