FDA 510(k)

Pluski Safe 1 Safety IV Catheter

Номер K: K210037 · 2022-03-25

Дата решения2022-03-25

Код продуктаFOZ

Консультативный комитетHO

РешениеSubstantially Equivalent

Описание устройства

Pluski Safe 1 Safety IV Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Mediplus (India) Limited. It received FDA 510(k) clearance on 2022-03-25 under 510(k) number K210037. 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 Pluski Safe 1 Safety IV Catheter?

Pluski Safe 1 Safety IV Catheter is a medical device that received FDA 510(k) clearance on 2022-03-25. The listed applicant is Mediplus (India) Limited. The 510(k) number is K210037.

When did Pluski Safe 1 Safety IV Catheter receive FDA 510(k) clearance?

Pluski Safe 1 Safety IV Catheter received FDA 510(k) clearance on 2022-03-25, under 510(k) number K210037.

Who is the listed applicant for Pluski Safe 1 Safety IV Catheter?

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

What is the FDA product code for Pluski Safe 1 Safety IV Catheter?

The FDA product code for Pluski Safe 1 Safety 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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