FDA 510(k)

下一代進入式心导管

K 號：K234074 · 2024-07-02

決定日期2024-07-02

產品代碼QJP

諮詢委員會履歷

決定相當於

器材摘要

Next Generation Access Catheter 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 K234074. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Next Generation Access Catheter?

Next Generation Access Catheter 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 K234074.

When did Next Generation Access Catheter receive FDA 510(k) clearance?

Next Generation Access Catheter received FDA 510(k) clearance on 2024-07-02, under 510(k) number K234074.

Who is the listed applicant for Next Generation Access Catheter?

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 Access Catheter?

The FDA product code for Next Generation Access Catheter is QJP.

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。

K260199SLIM 微导管 K254223下一代 088 管子 K254221Optima 結構系統（OptiOne 結構系統）K252569載體XL輸送導管 K252700Optima 結構系統（Optima 包裝結構系統）K243948Raptor 吸引針管；Balt 吸引管路組

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相關器械（代碼：QJP）

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。

K260220路92醫療全長046進入系統Route 92 Medical, Inc.K26227770 神經導引針管Piraeus Medical, Inc.K261176Zoom 4S 管針Imperative Care, Inc.K254071p17 XR 微导管Wallaby Medical K260199SLIM 微导管Balt USA, LLC K253901蟻蟻88 接通導管Perfuze, Ltd.

官方來源

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