FDA 510(k)

EasyPass Guidewire

Номер K: K153264 · 2016-05-19

Дата решения2016-05-19

Код продуктаOCY

Консультативный комитетGU

РешениеSubstantially Equivalent

Описание устройства

EasyPass Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Medi-Globe Corporation. It received FDA 510(k) clearance on 2016-05-19 under 510(k) number K153264. The device is classified under product code OCY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the EasyPass Guidewire?

EasyPass Guidewire is a medical device that received FDA 510(k) clearance on 2016-05-19. The listed applicant is Medi-Globe Corporation. The 510(k) number is K153264.

When did EasyPass Guidewire receive FDA 510(k) clearance?

EasyPass Guidewire received FDA 510(k) clearance on 2016-05-19, under 510(k) number K153264.

Who is the listed applicant for EasyPass Guidewire?

The FDA 510(k) record lists Medi-Globe Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EasyPass Guidewire?

The FDA product code for EasyPass Guidewire is OCY.

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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