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FDA 510(k)

希爾茲食道支架

K 號:K223266 · 2024-01-16

決定日期2024-01-16
產品代碼ESW
諮詢委員會SU 請提供完整的描述文本,以便我進行翻譯。
決定相當於

器材摘要

Hilzo Esophageal Stents is the device name listed in this FDA 510(k) record. The listed applicant is Thoracent, Inc.. It received FDA 510(k) clearance on 2024-01-16 under 510(k) number K223266. The device is classified under product code ESW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Hilzo Esophageal Stents?

Hilzo Esophageal Stents is a medical device that received FDA 510(k) clearance on 2024-01-16. The listed applicant is Thoracent, Inc.. The 510(k) number is K223266.

When did Hilzo Esophageal Stents receive FDA 510(k) clearance?

Hilzo Esophageal Stents received FDA 510(k) clearance on 2024-01-16, under 510(k) number K223266.

Who is the listed applicant for Hilzo Esophageal Stents?

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

What is the FDA product code for Hilzo Esophageal Stents?

The FDA product code for Hilzo Esophageal Stents is ESW.

相關臨床試驗

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相關器械(代碼:ESW)

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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