FDA 510(k)

Pressure Injectable Midline Catheter от Arrow

Номер K: K213855 · 2022-09-02

ЗаявительArrow International, LLC Subsidiary of Teleflex Incorporated

Дата решения2022-09-02

Код продуктаPND

Консультативный комитетHO

РешениеSubstantially Equivalent

Описание устройства

Arrow Pressure Injectable Midline Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Arrow International, LLC Subsidiary of Teleflex Incorporated. It received FDA 510(k) clearance on 2022-09-02 under 510(k) number K213855. The device is classified under product code PND. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Arrow Pressure Injectable Midline Catheter?

Arrow Pressure Injectable Midline Catheter is a medical device that received FDA 510(k) clearance on 2022-09-02. The listed applicant is Arrow International, LLC Subsidiary of Teleflex Incorporated. The 510(k) number is K213855.

When did Arrow Pressure Injectable Midline Catheter receive FDA 510(k) clearance?

Arrow Pressure Injectable Midline Catheter received FDA 510(k) clearance on 2022-09-02, under 510(k) number K213855.

Who is the listed applicant for Arrow Pressure Injectable Midline Catheter?

The FDA 510(k) record lists Arrow International, LLC Subsidiary of Teleflex Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Arrow Pressure Injectable Midline Catheter?

The FDA product code for Arrow Pressure Injectable Midline Catheter is PND.

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: PND)

K252402Midline CatheterTerumo Medical Products (Hangzhou) Co., Ltd.K213203Provena(TM) Midline CatheterC.R. Bard, Inc.K210047Stiletto Extended Dwell CatheterPiper Access, LLC K192802primeMidline CathetersPfm Medical, Inc.K181208Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL CatheterVygon USA K173114primeMidline CathetersPfm Medical, Inc.

Официальный источник

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