PTA 气球导管 (PVQ)，MIT PTA 氣球导管 (PVQ)
K 號：K201246 · 2021-08-03
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器材摘要
PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ) is the device name listed in this FDA 510(k) record. The listed applicant is Qualimed USA, LLC. It received FDA 510(k) clearance on 2021-08-03 under 510(k) number K201246. 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 PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ)?
PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ) is a medical device that received FDA 510(k) clearance on 2021-08-03. The listed applicant is Qualimed USA, LLC. The 510(k) number is K201246.
When did PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ) receive FDA 510(k) clearance?
PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ) received FDA 510(k) clearance on 2021-08-03, under 510(k) number K201246.
Who is the listed applicant for PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ)?
The FDA 510(k) record lists Qualimed USA, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ)?
The FDA product code for PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ) is LIT.
相關臨床試驗
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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
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