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FDA 510(k)

維納特克可轉換下腔靜脈過濾系統

K 號:K152765 · 2016-02-26

決定日期2016-02-26
產品代碼DTK
諮詢委員會履歷
決定相當於

器材摘要

VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM 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 2016-02-26 under 510(k) number K152765. The device is classified under product code DTK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM?

VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM is a medical device that received FDA 510(k) clearance on 2016-02-26. The listed applicant is B. Braun Interventional Systems, Inc.. The 510(k) number is K152765.

When did VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM receive FDA 510(k) clearance?

VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM received FDA 510(k) clearance on 2016-02-26, under 510(k) number K152765.

Who is the listed applicant for VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM?

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 VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM?

The FDA product code for VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM is DTK.

相關臨床試驗

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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。

相關器械(代碼:DTK)

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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