FDA 510(k)

虎追者及虎追者17再血管化設備

K 號：K203592 · 2021-03-23

決定日期2021-03-23

產品代碼NRY

諮詢委員會履歷

決定相當於

器材摘要

Tigertriever and Tigertriever 17 Revascularization Devce 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 2021-03-23 under 510(k) number K203592. 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 and Tigertriever 17 Revascularization Devce?

Tigertriever and Tigertriever 17 Revascularization Devce is a medical device that received FDA 510(k) clearance on 2021-03-23. The listed applicant is Rapid Medical , Ltd.. The 510(k) number is K203592.

When did Tigertriever and Tigertriever 17 Revascularization Devce receive FDA 510(k) clearance?

Tigertriever and Tigertriever 17 Revascularization Devce received FDA 510(k) clearance on 2021-03-23, under 510(k) number K203592.

Who is the listed applicant for Tigertriever and Tigertriever 17 Revascularization Devce?

The FDA 510(k) record lists Rapid Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tigertriever and Tigertriever 17 Revascularization Devce?

The FDA product code for Tigertriever and Tigertriever 17 Revascularization Devce 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 K253062虎獵者25再血管化設備 K251603虎獵者17超級再血管化設備 K233791Drivewire 24 導絲

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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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