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FDA 510(k)

ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System

K-Number: K221872 · 2023-03-30

ApplicantNova Eye Inc. (Business Name Nova Eye Medical)
Decision Date2023-03-30
Product CodeMPA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Nova Eye Inc. (Business Name Nova Eye Medical). The 510(k) number is K221872.

When was ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System approved by the FDA?

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

What company makes ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System?

ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System is manufactured by Nova Eye Inc. (Business Name Nova Eye Medical).

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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Related PubMed Literature

PMID: 40965839 A multi-stakeholder perspective on medical devices for children and adolescents with type 1 diabetes: huge unmet needs for the smallest. Journal of pediatric endocrinology & metabolism : JPEM (2025) PMID: 40069892 Enhanced mitochondrial function and delivery from adipose-derived stem cell spheres via the EZH2-H3K27me3-PPARγ pathway for advanced therapy. Stem cell research & therapy (2025)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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