PROTEUS PTA 擴張球囊心导管，具有栓子捕捉功能
K 號：K172494 · 2017-12-15
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器材摘要
PROTEUS PTA Balloon Catheter with Embolic Capture Feature is the device name listed in this FDA 510(k) record. The listed applicant is Angioslide, Ltd.. It received FDA 510(k) clearance on 2017-12-15 under 510(k) number K172494. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the PROTEUS PTA Balloon Catheter with Embolic Capture Feature?
PROTEUS PTA Balloon Catheter with Embolic Capture Feature is a medical device that received FDA 510(k) clearance on 2017-12-15. The listed applicant is Angioslide, Ltd.. The 510(k) number is K172494.
When did PROTEUS PTA Balloon Catheter with Embolic Capture Feature receive FDA 510(k) clearance?
PROTEUS PTA Balloon Catheter with Embolic Capture Feature received FDA 510(k) clearance on 2017-12-15, under 510(k) number K172494.
Who is the listed applicant for PROTEUS PTA Balloon Catheter with Embolic Capture Feature?
The FDA 510(k) record lists Angioslide, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PROTEUS PTA Balloon Catheter with Embolic Capture Feature?
The FDA product code for PROTEUS PTA Balloon Catheter with Embolic Capture Feature is LIT.
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：LIT）
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。
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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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