FDA 510(k)

PowerGlide Pro™ Midline Catheter

Номер K: K240359 · 2024-07-29

ЗаявительBecton, Dickinson and Company (Bard Access Systems, Inc.)

Дата решения2024-07-29

Код продуктаFOZ

Консультативный комитетHO

РешениеSubstantially Equivalent

Описание устройства

PowerGlide Pro™ Midline Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Becton, Dickinson and Company (Bard Access Systems, Inc.). It received FDA 510(k) clearance on 2024-07-29 under 510(k) number K240359. 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 PowerGlide Pro™ Midline Catheter?

PowerGlide Pro™ Midline Catheter is a medical device that received FDA 510(k) clearance on 2024-07-29. The listed applicant is Becton, Dickinson and Company (Bard Access Systems, Inc.). The 510(k) number is K240359.

When did PowerGlide Pro™ Midline Catheter receive FDA 510(k) clearance?

PowerGlide Pro™ Midline Catheter received FDA 510(k) clearance on 2024-07-29, under 510(k) number K240359.

Who is the listed applicant for PowerGlide Pro™ Midline Catheter?

The FDA 510(k) record lists Becton, Dickinson and Company (Bard Access Systems, Inc.) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PowerGlide Pro™ Midline Catheter?

The FDA product code for PowerGlide Pro™ Midline 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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