FDA 510(k)

下一代吸引針管；Balt吸引管路組

K 號：K234083 · 2024-07-02

決定日期2024-07-02

產品代碼NRY

諮詢委員會履歷

決定相當於

器材摘要

Next Generation Aspiration Catheter; Balt Aspiration Tubing Set is the device name listed in this FDA 510(k) record. The listed applicant is Balt USA, LLC. It received FDA 510(k) clearance on 2024-07-02 under 510(k) number K234083. The device is classified under product code NRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Next Generation Aspiration Catheter; Balt Aspiration Tubing Set?

Next Generation Aspiration Catheter; Balt Aspiration Tubing Set is a medical device that received FDA 510(k) clearance on 2024-07-02. The listed applicant is Balt USA, LLC. The 510(k) number is K234083.

When did Next Generation Aspiration Catheter; Balt Aspiration Tubing Set receive FDA 510(k) clearance?

Next Generation Aspiration Catheter; Balt Aspiration Tubing Set received FDA 510(k) clearance on 2024-07-02, under 510(k) number K234083.

Who is the listed applicant for Next Generation Aspiration Catheter; Balt Aspiration Tubing Set?

The FDA 510(k) record lists Balt USA, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Next Generation Aspiration Catheter; Balt Aspiration Tubing Set?

The FDA product code for Next Generation Aspiration Catheter; Balt Aspiration Tubing Set is NRY.

其他以 Balt USA, LLC 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：NRY）

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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官方來源

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