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FDA 510(k)

ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System

Número K: K221872 · 2023-03-30

RequerenteNova Eye Inc. (Business Name Nova Eye Medical)
Data da decisão2023-03-30
Código do produtoMPA
Comité consultivoGU
DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Dispositivos Relacionados (Código: MPA)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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