FDA 510(k)

虎獵者25再血管化設備

K 號：K253062 · 2026-03-12

決定日期2026-03-12

產品代碼NRY

諮詢委員會履歷

決定相當於

器材摘要

Tigertriever 25 Revascularization Device is the device name listed in this FDA 510(k) record. The listed applicant is Rapid Medical Ltd.. It received FDA 510(k) clearance on 2026-03-12 under 510(k) number K253062. 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 Tigertriever 25 Revascularization Device?

Tigertriever 25 Revascularization Device is a medical device that received FDA 510(k) clearance on 2026-03-12. The listed applicant is Rapid Medical Ltd.. The 510(k) number is K253062.

When did Tigertriever 25 Revascularization Device receive FDA 510(k) clearance?

Tigertriever 25 Revascularization Device received FDA 510(k) clearance on 2026-03-12, under 510(k) number K253062.

Who is the listed applicant for Tigertriever 25 Revascularization Device?

FDA 510(k) 記錄將 Rapid Medical 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 Tigertriever 25 Revascularization Device?

The FDA product code for Tigertriever 25 Revascularization Device is NRY.

其他以 Rapid Medical 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。

K253146超驅35導絲 K260617虎獵者13超級再血管化設備 K254006Drivewire 35 導絲 K251603虎獵者17超級再血管化設備 K233791Drivewire 24 導絲 K230429虎追者21再血管化設備，虎追者17再血管化設備，虎追者13再血管化設備

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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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