FDA 510(k)

EMBOGUARD 气球導管

K 號：K233924 · 2024-04-18

決定日期2024-04-18

產品代碼QJP

諮詢委員會履歷

決定相當於

器材摘要

EMBOGUARD Balloon Guide Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Neuravi Limited. It received FDA 510(k) clearance on 2024-04-18 under 510(k) number K233924. 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 EMBOGUARD Balloon Guide Catheter?

EMBOGUARD Balloon Guide Catheter is a medical device that received FDA 510(k) clearance on 2024-04-18. The listed applicant is Neuravi Limited. The 510(k) number is K233924.

When did EMBOGUARD Balloon Guide Catheter receive FDA 510(k) clearance?

EMBOGUARD Balloon Guide Catheter received FDA 510(k) clearance on 2024-04-18, under 510(k) number K233924.

Who is the listed applicant for EMBOGUARD Balloon Guide Catheter?

The FDA 510(k) record lists Neuravi Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EMBOGUARD Balloon Guide Catheter?

The FDA product code for EMBOGUARD Balloon Guide Catheter is QJP.

其他以 Neuravi Limited 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。

K251789EMBOTRAP III 血管重建設備 K212340EMBOGUARD 气球導管

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

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。