FDA 510(k)

ZOOM (71, 55, 45, 35) 再灌流針筒；ZOOM 吸引管

K 號：K202182 · 2020-09-02

決定日期2020-09-02

產品代碼NRY

諮詢委員會履歷

決定相當於

器材摘要

ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing is the device name listed in this FDA 510(k) record. The listed applicant is Imperative Care, Inc.. It received FDA 510(k) clearance on 2020-09-02 under 510(k) number K202182. 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 ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing?

ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing is a medical device that received FDA 510(k) clearance on 2020-09-02. The listed applicant is Imperative Care, Inc.. The 510(k) number is K202182.

When did ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing receive FDA 510(k) clearance?

ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing received FDA 510(k) clearance on 2020-09-02, under 510(k) number K202182.

Who is the listed applicant for ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing?

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

What is the FDA product code for ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing?

The FDA product code for ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing is NRY.

其他以 Imperative Care, Inc. 為申請人之記錄

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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。

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