FDA 510(k)

Mais Central Venous Catheter

Номер K: K221827 · 2023-06-23

ЗаявительSaudi Mais Co. For Medical Products

Дата решения2023-06-23

Код продуктаFOZ

Консультативный комитетHO

РешениеSubstantially Equivalent

Описание устройства

Mais Central Venous Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Saudi Mais Co. For Medical Products. It received FDA 510(k) clearance on 2023-06-23 under 510(k) number K221827. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Mais Central Venous Catheter?

Mais Central Venous Catheter is a medical device that received FDA 510(k) clearance on 2023-06-23. The listed applicant is Saudi Mais Co. For Medical Products. The 510(k) number is K221827.

When did Mais Central Venous Catheter receive FDA 510(k) clearance?

Mais Central Venous Catheter received FDA 510(k) clearance on 2023-06-23, under 510(k) number K221827.

Who is the listed applicant for Mais Central Venous Catheter?

The FDA 510(k) record lists Saudi Mais Co. For Medical Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mais Central Venous Catheter?

The FDA product code for Mais Central Venous Catheter is FOZ.

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.

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Связанные устройства (Код: FOZ)

K260432Ruby Intravascular CatheterVenocare, Inc.K260165Unimpregnated Central Venous CatheterSpectrum Vascular K261041ClearSafe Closed SystemMedSource Labs, LLC K260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLC K253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc.K252137BD Insyte™ IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.

Официальный источник

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