FDA 510(k)

載體XL輸送導管

K 號：K252569 · 2025-10-22

決定日期2025-10-22

產品代碼QJP

諮詢委員會履歷

決定相當於

器材摘要

Carrier XL Delivery 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 2025-10-22 under 510(k) number K252569. 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 Carrier XL Delivery Catheter?

Carrier XL Delivery Catheter is a medical device that received FDA 510(k) clearance on 2025-10-22. The listed applicant is Balt USA, LLC. The 510(k) number is K252569.

When did Carrier XL Delivery Catheter receive FDA 510(k) clearance?

Carrier XL Delivery Catheter received FDA 510(k) clearance on 2025-10-22, under 510(k) number K252569.

Who is the listed applicant for Carrier XL Delivery 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 Carrier XL Delivery Catheter?

The FDA product code for Carrier XL Delivery 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）K252700Optima 結構系統（Optima 包裝結構系統）K243948Raptor 吸引針管；Balt 吸引管路組 K251383Prestige 環繞系統（Prestige 装箱線擴充）

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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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