注射針栓
K 號：K173556 · 2018-07-13
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器材摘要
Injection Screw is the device name listed in this FDA 510(k) record. The listed applicant is Biedermann Medtech, Inc.. It received FDA 510(k) clearance on 2018-07-13 under 510(k) number K173556. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
常見問題
What is the Injection Screw?
Injection Screw is a medical device that received FDA 510(k) clearance on 2018-07-13. The listed applicant is Biedermann Medtech, Inc.. The 510(k) number is K173556.
When did Injection Screw receive FDA 510(k) clearance?
Injection Screw received FDA 510(k) clearance on 2018-07-13, under 510(k) number K173556.
Who is the listed applicant for Injection Screw?
The FDA 510(k) record lists Biedermann Medtech, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Injection Screw?
The FDA product code for Injection Screw is HWC. This falls under the Cardiovascular category.
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。
相關器械（代碼：HWC）
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
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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