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FDA 510(k)

無菌性膽結石回收氣球針筒,回收氣球/短針兼容

K 號:K211021 · 2022-05-06

決定日期2022-05-06
產品代碼FGE
諮詢委員會GU
決定相當於

器材摘要

Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible is the device name listed in this FDA 510(k) record. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2022-05-06 under 510(k) number K211021. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible?

Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible is a medical device that received FDA 510(k) clearance on 2022-05-06. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K211021.

When did Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible receive FDA 510(k) clearance?

Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible received FDA 510(k) clearance on 2022-05-06, under 510(k) number K211021.

Who is the listed applicant for Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible?

The FDA 510(k) record lists Micro-Tech (Nanjing) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible?

The FDA product code for Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible is FGE.

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其他以 Micro-Tech (Nanjing) Co., Ltd. 為申請人之記錄

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相關器械(代碼:FGE)

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。

官方來源

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