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FDA 510(k)

三邊楔形PTA評分擴張針狀導管

K 號:K241478 · 2024-10-22

決定日期2024-10-22
產品代碼PNO
諮詢委員會履歷
決定相當於

器材摘要

Tri-Wedge PTA Scoring Balloon Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Brosmed Medical Co., Ltd.. It received FDA 510(k) clearance on 2024-10-22 under 510(k) number K241478. 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 Tri-Wedge PTA Scoring Balloon Dilatation Catheter?

Tri-Wedge PTA Scoring Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2024-10-22. The listed applicant is Brosmed Medical Co., Ltd.. The 510(k) number is K241478.

When did Tri-Wedge PTA Scoring Balloon Dilatation Catheter receive FDA 510(k) clearance?

Tri-Wedge PTA Scoring Balloon Dilatation Catheter received FDA 510(k) clearance on 2024-10-22, under 510(k) number K241478.

Who is the listed applicant for Tri-Wedge PTA Scoring Balloon Dilatation Catheter?

The FDA 510(k) record lists Brosmed Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tri-Wedge PTA Scoring Balloon Dilatation Catheter?

The FDA product code for Tri-Wedge PTA Scoring Balloon Dilatation Catheter is PNO.

相關臨床試驗

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其他以 Brosmed Medical Co., Ltd. 為申請人之記錄

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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。

官方來源

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