FDA 510(k)

MedSource CathMED IV Catheter

Номер K: K193278 · 2020-08-07

Дата решения2020-08-07

Код продуктаFOZ

Консультативный комитетHO

РешениеSubstantially Equivalent

Описание устройства

MedSource CathMED IV Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Medsource Labs. It received FDA 510(k) clearance on 2020-08-07 under 510(k) number K193278. 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 MedSource CathMED IV Catheter?

MedSource CathMED IV Catheter is a medical device that received FDA 510(k) clearance on 2020-08-07. The listed applicant is Medsource Labs. The 510(k) number is K193278.

When did MedSource CathMED IV Catheter receive FDA 510(k) clearance?

MedSource CathMED IV Catheter received FDA 510(k) clearance on 2020-08-07, under 510(k) number K193278.

Who is the listed applicant for MedSource CathMED IV Catheter?

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

What is the FDA product code for MedSource CathMED IV Catheter?

The FDA product code for MedSource CathMED IV 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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