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FDA 510(k)

SeQuent Neo 體外透壁冠狀動脈成形術（PTCA）氣球心导管

K 號：K162625 · 2017-06-12

申請人B. Braun Interventional Systems, Inc.
決定日期2017-06-12
產品代碼LOX
諮詢委員會履歷
決定相當於

器材摘要

SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters is the device name listed in this FDA 510(k) record. The listed applicant is B. Braun Interventional Systems, Inc.. It received FDA 510(k) clearance on 2017-06-12 under 510(k) number K162625. The device is classified under product code LOX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters?

SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters is a medical device that received FDA 510(k) clearance on 2017-06-12. The listed applicant is B. Braun Interventional Systems, Inc.. The 510(k) number is K162625.

When did SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters receive FDA 510(k) clearance?

SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters received FDA 510(k) clearance on 2017-06-12, under 510(k) number K162625.

Who is the listed applicant for SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters?

The FDA 510(k) record lists B. Braun Interventional Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters?

The FDA product code for SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters is LOX.

相關臨床試驗

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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其他以 B. Braun Interventional Systems, Inc. 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。

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相關器械（代碼：LOX）

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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