FDA 510(k)

Merit RadialFlo Arterial Catheter

Номер K: K182538 · 2019-01-16

ЗаявительMerit Medical Singapore Pte. , Ltd.

Дата решения2019-01-16

Код продуктаFOZ

Консультативный комитетHO

РешениеSubstantially Equivalent

Описание устройства

Merit RadialFlo Arterial Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Singapore Pte. , Ltd.. It received FDA 510(k) clearance on 2019-01-16 under 510(k) number K182538. 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 Merit RadialFlo Arterial Catheter?

Merit RadialFlo Arterial Catheter is a medical device that received FDA 510(k) clearance on 2019-01-16. The listed applicant is Merit Medical Singapore Pte. , Ltd.. The 510(k) number is K182538.

When did Merit RadialFlo Arterial Catheter receive FDA 510(k) clearance?

Merit RadialFlo Arterial Catheter received FDA 510(k) clearance on 2019-01-16, under 510(k) number K182538.

Who is the listed applicant for Merit RadialFlo Arterial Catheter?

The FDA 510(k) record lists Merit Medical Singapore Pte. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Merit RadialFlo Arterial Catheter?

The FDA product code for Merit RadialFlo Arterial 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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