FDA 510(k)

Cook® Spectrum® 2 MRC Central Venous Catheter

Номер K: K223648 · 2023-02-03

Дата решения2023-02-03

Код продуктаFOZ

Консультативный комитетHO

РешениеSubstantially Equivalent

Описание устройства

Cook® Spectrum® 2 MRC Central Venous Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Cook Advanced Technologies. It received FDA 510(k) clearance on 2023-02-03 under 510(k) number K223648. 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 Cook® Spectrum® 2 MRC Central Venous Catheter?

Cook® Spectrum® 2 MRC Central Venous Catheter is a medical device that received FDA 510(k) clearance on 2023-02-03. The listed applicant is Cook Advanced Technologies. The 510(k) number is K223648.

When did Cook® Spectrum® 2 MRC Central Venous Catheter receive FDA 510(k) clearance?

Cook® Spectrum® 2 MRC Central Venous Catheter received FDA 510(k) clearance on 2023-02-03, under 510(k) number K223648.

Who is the listed applicant for Cook® Spectrum® 2 MRC Central Venous Catheter?

The FDA 510(k) record lists Cook Advanced Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cook® Spectrum® 2 MRC Central Venous Catheter?

The FDA product code for Cook® Spectrum® 2 MRC 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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