FDA 510(k)Aperta NSE PTA Balloon Dilatation Catheter
K 號：K243944 · 2025-04-22
決定日期2025-04-22
產品代碼PNO
諮詢委員會履歷
決定相當於
器材摘要
Aperta NSE PTA Balloon Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Goodman Co., Ltd.. It received FDA 510(k) clearance on 2025-04-22 under 510(k) number K243944. 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 Aperta NSE PTA Balloon Dilatation Catheter?
Aperta NSE PTA Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2025-04-22. The listed applicant is Goodman Co., Ltd.. The 510(k) number is K243944.
When did Aperta NSE PTA Balloon Dilatation Catheter receive FDA 510(k) clearance?
Aperta NSE PTA Balloon Dilatation Catheter received FDA 510(k) clearance on 2025-04-22, under 510(k) number K243944.
Who is the listed applicant for Aperta NSE PTA Balloon Dilatation Catheter?
The FDA 510(k) record lists Goodman Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Aperta NSE PTA Balloon Dilatation Catheter?
The FDA product code for Aperta NSE PTA Balloon Dilatation Catheter is PNO.
相關臨床試驗
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其他以 Goodman Co., Ltd. 為申請人之記錄
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。
K232013Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14560040 AW18-05070040/AA18-05070040, AW18-09070040/AA18-09070040, AW18-14570040, AW18-05080040/AA18-05080040, AW18-09080040/AA18-09080040, AW18-14580040)
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。
K261778JADE 分數 PTA 評分 擴張針管OrbusNeich Medical (Shenzhen) Co., Ltd.K260012超分數™ 焦點力量PTA氣球Bard Peripheral Vascular, Inc.K242254D·Kutting™ LL 頸外週圍評分擴張針管Dk Medical Technology Co., Ltd.K241478三邊楔形PTA評分擴張針狀導管Brosmed Medical Co., Ltd.K232258XO Constrain™ 皮膚穿剌經皮腔內血管成形術限制性心导管Transit Scientific, LLCK232013Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14560040 AW18-05070040/AA18-05070040, AW18-09070040/AA18-09070040, AW18-14570040, AW18-05080040/AA18-05080040, AW18-09080040/AA18-09080040, AW18-14580040)Goodman Co., Ltd.