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FDA 510(k)

Riptide 吸引系統

K 號：K243080 · 2024-10-29

申請人Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
決定日期2024-10-29
產品代碼NRY
諮詢委員會履歷
決定相當於

器材摘要

Riptide Aspiration System is the device name listed in this FDA 510(k) record. The listed applicant is Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. It received FDA 510(k) clearance on 2024-10-29 under 510(k) number K243080. 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 Riptide Aspiration System?

Riptide Aspiration System is a medical device that received FDA 510(k) clearance on 2024-10-29. The listed applicant is Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. The 510(k) number is K243080.

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

Riptide Aspiration System received FDA 510(k) clearance on 2024-10-29, under 510(k) number K243080.

Who is the listed applicant for Riptide Aspiration System?

The FDA 510(k) record lists Micro Therapeutics, Inc. d/b/a ev3 Neurovascular as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Riptide Aspiration System?

The FDA product code for Riptide Aspiration System is NRY.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Micro Therapeutics, Inc. d/b/a ev3 Neurovascular 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。

K241388Rist 079 靜脈通路導引針；Rist 071 静脈通路導引針；Rist 選擇性靜脈通路針K243418Riptide™ 吸引泵；Riptide™ 收集罐及中間管路K211990Rist 071 體外循環導管輔助導管K203432Axium 可拆卸线圈；Axium Prime 可拆卸线圈K203358單一花束 X 再血管化設備K202850Concerto Versa, 可拆式線圈

查看所有 27 項裝置 →

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。

K261089極端064再灌流導管；極端076再灌流導管；極端吸引管套組Maduro Medical, Inc.K260617虎獵者13超級再血管化設備Rapid Medical Ltd.K262398CEREGLIDE 57 中間導管；Cerenovus 吸引管組CERENOVUS, Inc.K262399蜈蚣系統Perfuze, Ltd.K262391APRO 35 Swift 管腔內導管及Alembic 吸引管Alembic, LLCK260002索福克勒斯吸引系統（索福克勒斯70吸引針）Scientia Vascular, Inc.

官方來源

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