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FDA 510(k)

ITrack 先進型 Canaloplasty 微导管配備先進輸送系統

K 號：K221872 · 2023-03-30

申請人Nova Eye Inc. (Business Name Nova Eye Medical)
決定日期2023-03-30
產品代碼MPA
諮詢委員會GU
決定相當於

器材摘要

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.

常見問題

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.

相關臨床試驗

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：MPA）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K253468Nova Eye iTrack™ 250A 管道成形術微導管（iTrack™ 250A）Nova Eye, Inc.K242184Alcon 27GA Chandelier（8065000252）；Alcon 27+ DS廣角內腔照明器（8065000253）；Alcon 27+ DS內腔照明器（8065000256）；Alcon Laboratories, Inc.K233653中場光導管，23ga（3269.M06-00）；中場光導管，25ga（3269.M05-00）；中場光導管，27ga（3269.M04-00）Peregrine Surgical, LLCK202670名照明探針搭配切換器Oculight , Ltd.

官方來源

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