導管，經皮腔內冠狀動脈成形術（PTCA），切割/劃痕
PMA 核准號：P200041 · 2026-07-31
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決定日期2026-07-31
PMA 編號P200041
產品代碼NWX
器械分類3 類
醫療專科U
諮詢委員會履歷
器材摘要
Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring is the device name listed in this FDA 510(k) record. The listed applicant is OrbusNeich Medical (Shenzhen) Co., Ltd.. It received FDA 510(k) clearance on 2026-07-31. The device is classified under product code NWX. It was reviewed by the CV advisory panel.
常見問題
What is the Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring?
Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring is a medical device that received FDA 510(k) clearance on 2026-07-31. The listed applicant is OrbusNeich Medical (Shenzhen) Co., Ltd..
When did Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring receive FDA 510(k) clearance?
The clearance date for Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring can be found in the official FDA records.
誰是針對「心臟內腔血管成形術（PTCA）導管，切割/劃痕」所列的申請人？
FDA 510(k) 記錄將OrbusNeich Medical (Shenzhen) Co., Ltd. 列為申請人。這並不單獨確立設備製造商的身份。
FDA產品代碼為Catheter, percutaneous transluminal coronary angioplasty (PTCA), 切割/劃痕的什麼？
FDA產品代碼對於心导管、經皮腔內冠狀動脈成形術（PTCA）、切割/劃痕為 NWX。
相關臨床試驗
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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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