FDA 510(k)

Lynx 吸引針系統

K 號：K254276 · 2026-05-07

決定日期2026-05-07

產品代碼NRY

諮詢委員會履歷

決定相當於

器材摘要

Lynx Aspiration Catheter System is the device name listed in this FDA 510(k) record. The listed applicant is Q’Apel Medical, Inc.. It received FDA 510(k) clearance on 2026-05-07 under 510(k) number K254276. 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 Lynx Aspiration Catheter System?

Lynx Aspiration Catheter System is a medical device that received FDA 510(k) clearance on 2026-05-07. The listed applicant is Q’Apel Medical, Inc.. The 510(k) number is K254276.

When did Lynx Aspiration Catheter System receive FDA 510(k) clearance?

Lynx Aspiration Catheter System received FDA 510(k) clearance on 2026-05-07, under 510(k) number K254276.

Who is the listed applicant for Lynx Aspiration Catheter System?

The FDA 510(k) record lists Q’Apel Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lynx Aspiration Catheter System?

The FDA product code for Lynx Aspiration Catheter System is NRY.

其他以 Q’Apel Medical, Inc. 為申請人之記錄

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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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