MC-Subtalar™ II
K 號：K160548 · 2016-04-29
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器材摘要
MC-Subtalar(TM) II is the device name listed in this FDA 510(k) record. The listed applicant is Merete Medical GmbH. It received FDA 510(k) clearance on 2016-04-29 under 510(k) number K160548. 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 MC-Subtalar(TM) II?
MC-Subtalar(TM) II is a medical device that received FDA 510(k) clearance on 2016-04-29. The listed applicant is Merete Medical GmbH. The 510(k) number is K160548.
When did MC-Subtalar(TM) II receive FDA 510(k) clearance?
MC-Subtalar(TM) II received FDA 510(k) clearance on 2016-04-29, under 510(k) number K160548.
Who is the listed applicant for MC-Subtalar(TM) II?
The FDA 510(k) record lists Merete Medical GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MC-Subtalar(TM) II?
The FDA product code for MC-Subtalar(TM) II is HWC. This falls under the Cardiovascular category.
相關臨床試驗
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其他以 Merete Medical GmbH 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。
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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