EMBA 時鐘形周邊栓塊移除設備 (PED)
K 號：K200083 · 2020-02-14
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器材摘要
EMBA Hourglass Peripheral Embolization Device (PED) is the device name listed in this FDA 510(k) record. The listed applicant is Embolic Acceleration, LLC. It received FDA 510(k) clearance on 2020-02-14 under 510(k) number K200083. The device is classified under product code KRD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the EMBA Hourglass Peripheral Embolization Device (PED)?
EMBA Hourglass Peripheral Embolization Device (PED) is a medical device that received FDA 510(k) clearance on 2020-02-14. The listed applicant is Embolic Acceleration, LLC. The 510(k) number is K200083.
When did EMBA Hourglass Peripheral Embolization Device (PED) receive FDA 510(k) clearance?
EMBA Hourglass Peripheral Embolization Device (PED) received FDA 510(k) clearance on 2020-02-14, under 510(k) number K200083.
Who is the listed applicant for EMBA Hourglass Peripheral Embolization Device (PED)?
The FDA 510(k) record lists Embolic Acceleration, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EMBA Hourglass Peripheral Embolization Device (PED)?
The FDA product code for EMBA Hourglass Peripheral Embolization Device (PED) is KRD.
相關臨床試驗
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相關器械（代碼：KRD）
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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