FDA 510(k)

Riptide™ 吸引泵；Riptide™ 收集罐及中間管路

K 號：K243418 · 2024-12-02

申請人Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

決定日期2024-12-02

產品代碼JCX

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate Tubing 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 2024-12-02 under 510(k) number K243418. The device is classified under product code JCX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate Tubing?

Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate Tubing is a medical device that received FDA 510(k) clearance on 2024-12-02. The listed applicant is Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. The 510(k) number is K243418.

When did Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate Tubing receive FDA 510(k) clearance?

Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate Tubing received FDA 510(k) clearance on 2024-12-02, under 510(k) number K243418.

Who is the listed applicant for Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate Tubing?

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 Pump; Riptide™ Collection Canister with Intermediate Tubing?

The FDA product code for Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate Tubing is JCX.

其他以 Micro Therapeutics, Inc. d/b/a ev3 Neurovascular 為申請人之記錄

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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 K243080Riptide 吸引系統 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

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相關器械（代碼：JCX）

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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