FDA 510(k)

SLIM 微导管

K 號：K260199 · 2026-07-13

決定日期2026-07-13

產品代碼QJP

諮詢委員會履歷

決定相當於

器材摘要

SLIM Microcatheter 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 2026-07-13 under 510(k) number K260199. 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 SLIM Microcatheter?

SLIM Microcatheter is a medical device that received FDA 510(k) clearance on 2026-07-13. The listed applicant is Balt USA, LLC. The 510(k) number is K260199.

When did SLIM Microcatheter receive FDA 510(k) clearance?

SLIM Microcatheter received FDA 510(k) clearance on 2026-07-13, under 510(k) number K260199.

Who is the listed applicant for SLIM Microcatheter?

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 SLIM Microcatheter?

The FDA product code for SLIM Microcatheter 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。

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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。

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