FLEX 分數導管
K 號：K152789 · 2016-05-25
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器材摘要
FLEX SCORING CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Venturemed Group. It received FDA 510(k) clearance on 2016-05-25 under 510(k) number K152789. The device is classified under product code PNO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the FLEX SCORING CATHETER?
FLEX SCORING CATHETER is a medical device that received FDA 510(k) clearance on 2016-05-25. The listed applicant is Venturemed Group. The 510(k) number is K152789.
When did FLEX SCORING CATHETER receive FDA 510(k) clearance?
FLEX SCORING CATHETER received FDA 510(k) clearance on 2016-05-25, under 510(k) number K152789.
Who is the listed applicant for FLEX SCORING CATHETER?
The FDA 510(k) record lists Venturemed Group as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for FLEX SCORING CATHETER?
The FDA product code for FLEX SCORING CATHETER is PNO.
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相關器械（代碼：PNO）
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
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