FDA 510(k)

AHMED ClearPath青光眼引流設備

K 號：K182518 · 2019-01-18

決定日期2019-01-18

產品代碼KYF

諮詢委員會此為醫療器材法規文本之翻譯。根據醫療法規翻譯政策，以下為繁體中文譯文：本文件概述適用於醫療器材之監管架構，包括美國食品藥物管理局（FDA）之上市前審查程序。第510(k)條途徑適用於與已合法上市器材（predicate device）實質等效之器材，而上市前核准（PMA）則為最高風險等級（Class III）器材所要求。臨床證據可能引用NCT編號之試驗登記，或PMID編號之同行評審文獻。所有產品名稱、公司名稱、識別碼及統一資源定位符（URL）均保留原文，以確保可追溯性及法規提交之完整性。

決定相當於

器材摘要

AHMED ClearPath Glaucoma Drainage Device is the device name listed in this FDA 510(k) record. The listed applicant is New World Medical, Inc.. It received FDA 510(k) clearance on 2019-01-18 under 510(k) number K182518. The device is classified under product code KYF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AHMED ClearPath Glaucoma Drainage Device?

AHMED ClearPath Glaucoma Drainage Device is a medical device that received FDA 510(k) clearance on 2019-01-18. The listed applicant is New World Medical, Inc.. The 510(k) number is K182518.

When did AHMED ClearPath Glaucoma Drainage Device receive FDA 510(k) clearance?

AHMED ClearPath Glaucoma Drainage Device received FDA 510(k) clearance on 2019-01-18, under 510(k) number K182518.

Who is the listed applicant for AHMED ClearPath Glaucoma Drainage Device?

The FDA 510(k) record lists New World Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AHMED ClearPath Glaucoma Drainage Device?

The FDA product code for AHMED ClearPath Glaucoma Drainage Device is KYF.

其他以 New World Medical, Inc. 為申請人之記錄

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。

K243503VIA360™手術系統 K220891Kahook雙刀滑動（KDB滑動）K231051Ahmed® Glaucoma Valve Model FP8 K230975Ahmed® Glaucoma Valve Model FP7 K211680Streamline外科系統 K171451Ahmed Glaucoma Valve Model FP8

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相關器械（代碼：KYF）

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。

K231051Ahmed® Glaucoma Valve Model FP8New World Medical, Inc.K230975Ahmed® Glaucoma Valve Model FP7New World Medical, Inc.K220032iStent無限 trabecular 微分流導系統，型號 iS3Glaukos Corporation K171451Ahmed Glaucoma Valve Model FP8New World Medical, Inc.K161457XEN 青光眼治療系統Allergan, Inc.K162060Ahmed Glaucoma ValveNew World Medical, Inc.

官方來源

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