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FDA 510(k)

ALN 選擇性腹腔静脉過濾器 (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK)

K 號：K241507 · 2024-06-26

申請人Aln S.A.R.L.
決定日期2024-06-26
產品代碼DTK
諮詢委員會履歷
決定相當於

器材摘要

ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK) is the device name listed in this FDA 510(k) record. The listed applicant is Aln S.A.R.L.. It received FDA 510(k) clearance on 2024-06-26 under 510(k) number K241507. 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 ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK)?

ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK) is a medical device that received FDA 510(k) clearance on 2024-06-26. The listed applicant is Aln S.A.R.L.. The 510(k) number is K241507.

When did ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK) receive FDA 510(k) clearance?

ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK) received FDA 510(k) clearance on 2024-06-26, under 510(k) number K241507.

Who is the listed applicant for ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK)?

The FDA 510(k) record lists Aln S.A.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK)?

The FDA product code for ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK) is DTK.

相關臨床試驗

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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。

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