FDA 510(k)

Low Potassium Dextran Solution with Tris Diluent

Номер K: K153384 · 2016-02-19

ЗаявительUnited Therapeutics Corporation

Дата решения2016-02-19

Код продуктаKDN

Консультативный комитетGU

РешениеSubstantially Equivalent

Описание устройства

Low Potassium Dextran Solution with Tris Diluent is the device name listed in this FDA 510(k) record. The listed applicant is United Therapeutics Corporation. It received FDA 510(k) clearance on 2016-02-19 under 510(k) number K153384. The device is classified under product code KDN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Low Potassium Dextran Solution with Tris Diluent?

Low Potassium Dextran Solution with Tris Diluent is a medical device that received FDA 510(k) clearance on 2016-02-19. The listed applicant is United Therapeutics Corporation. The 510(k) number is K153384.

When did Low Potassium Dextran Solution with Tris Diluent receive FDA 510(k) clearance?

Low Potassium Dextran Solution with Tris Diluent received FDA 510(k) clearance on 2016-02-19, under 510(k) number K153384.

Who is the listed applicant for Low Potassium Dextran Solution with Tris Diluent?

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

What is the FDA product code for Low Potassium Dextran Solution with Tris Diluent?

The FDA product code for Low Potassium Dextran Solution with Tris Diluent is KDN.

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: KDN)

K261644Perfadex PlusXvivo Perfusion AB K260456VI°Port™ Liver Preservation SystemTraferox Technologies, Inc.K254305BAROguard Donor Lung Preservation SystemParagonix Technologies, Inc.K243618EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250)Bridge TO Life K243870X°Port Lung Preservation System; X°Port Lung Preservation SolutionTraferox Technologies, Inc.K243998DCX Disposable Cassette (DCX)Institut Geroges Lopez

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.