FDA 510(k)

ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System

Номер K: K221872 · 2023-03-30

ЗаявительNova Eye Inc. (Business Name Nova Eye Medical)

Дата решения2023-03-30

Код продуктаMPA

Консультативный комитетGU

РешениеSubstantially Equivalent

Описание устройства

ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Nova Eye Inc. (Business Name Nova Eye Medical). It received FDA 510(k) clearance on 2023-03-30 under 510(k) number K221872. The device is classified under product code MPA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System?

ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System is a medical device that received FDA 510(k) clearance on 2023-03-30. The listed applicant is Nova Eye Inc. (Business Name Nova Eye Medical). The 510(k) number is K221872.

When did ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System receive FDA 510(k) clearance?

ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System received FDA 510(k) clearance on 2023-03-30, under 510(k) number K221872.

Who is the listed applicant for ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System?

The FDA 510(k) record lists Nova Eye Inc. (Business Name Nova Eye Medical) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System?

The FDA product code for ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System is MPA.

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: MPA)

K253468Nova Eye iTrack™ 250A Canaloplasty Microcatheter (iTrack™ 250A)Nova Eye, Inc.K242184Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);Alcon Laboratories, Inc.K233653Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00)Peregrine Surgical, LLC K202670Nam illumination probe with chopperOculight , Ltd.

Официальный источник

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