FDA 510(k)

Mikro-Cath Pressure Catheter

Номер K: K163376 · 2017-03-10

ЗаявительMillar, Inc.

Дата решения2017-03-10

Код продуктаDXO

Консультативный комитетCV

РешениеSubstantially Equivalent

Описание устройства

Mikro-Cath Pressure Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Millar, Inc.. It received FDA 510(k) clearance on 2017-03-10 under 510(k) number K163376. The device is classified under product code DXO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Mikro-Cath Pressure Catheter?

Mikro-Cath Pressure Catheter is a medical device that received FDA 510(k) clearance on 2017-03-10. The listed applicant is Millar, Inc.. The 510(k) number is K163376.

When did Mikro-Cath Pressure Catheter receive FDA 510(k) clearance?

Mikro-Cath Pressure Catheter received FDA 510(k) clearance on 2017-03-10, under 510(k) number K163376.

Who is the listed applicant for Mikro-Cath Pressure Catheter?

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

What is the FDA product code for Mikro-Cath Pressure Catheter?

The FDA product code for Mikro-Cath Pressure Catheter is DXO.

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: DXO)

K251367OptoMonitor 3Opsens, Inc.K241418OptoMonitor 3Opsens, Inc.K233904ACIST RXi Система (016616); ACIST Navvus II Катетер (016675_Acist Medical Systems, Inc.K222216TruWave Disposable Pressure TransducerEdwards Lifesciences, LLC K202943OptoMonitor 3Opsens, Inc.K193620OptoMonitor 3Opsens, Inc.

Официальный источник

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