All’InCath 035M PTA 擴張球囊導管
K 號：K191275 · 2020-01-15
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器材摘要
All’InCath 035M PTA Balloon Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Nexstep Medical. It received FDA 510(k) clearance on 2020-01-15 under 510(k) number K191275. 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 All’InCath 035M PTA Balloon Dilatation Catheter?
All’InCath 035M PTA Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2020-01-15. The listed applicant is Nexstep Medical. The 510(k) number is K191275.
When did All’InCath 035M PTA Balloon Dilatation Catheter receive FDA 510(k) clearance?
All’InCath 035M PTA Balloon Dilatation Catheter received FDA 510(k) clearance on 2020-01-15, under 510(k) number K191275.
Who is the listed applicant for All’InCath 035M PTA Balloon Dilatation Catheter?
The FDA 510(k) record lists Nexstep Medical as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for All’InCath 035M PTA Balloon Dilatation Catheter?
The FDA product code for All’InCath 035M PTA Balloon Dilatation Catheter 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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