FDA 510(k)

蜈蚣088進入導管；蜈蚣070吸引導管；Perfuze吸引管路組

K 號：K242504 · 2024-09-20

決定日期2024-09-20

產品代碼NRY

諮詢委員會履歷

決定相當於

器材摘要

Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set is the device name listed in this FDA 510(k) record. The listed applicant is Perfuze, Ltd.. It received FDA 510(k) clearance on 2024-09-20 under 510(k) number K242504. 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 Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set?

Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set is a medical device that received FDA 510(k) clearance on 2024-09-20. The listed applicant is Perfuze, Ltd.. The 510(k) number is K242504.

When did Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set receive FDA 510(k) clearance?

Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set received FDA 510(k) clearance on 2024-09-20, under 510(k) number K242504.

Who is the listed applicant for Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set?

FDA 510(k) 記錄將 Perfuze, Ltd. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set?

The FDA product code for Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set is NRY.

其他以 Perfuze, Ltd. 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。

K262399蜈蚣系統 K253901蟻蟻88 接通導管 K253590蜈蚣系統 K252392Millipede70 吸引針管；Perfuze 吸引管路組 K250012蜈蚣070 吸引針管；Perfuze 吸引管路組 K240711Zipline 接觸導管

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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。

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, LLC K260002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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