FDA 510(k)

CERENOVUS 大孔內管；CERENOVUS 吸引管路組

K 號：K193380 · 2020-07-20

決定日期2020-07-20

產品代碼NRY

諮詢委員會履歷

決定相當於

器材摘要

CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set is the device name listed in this FDA 510(k) record. The listed applicant is Codman & Shurtleff, Inc.. It received FDA 510(k) clearance on 2020-07-20 under 510(k) number K193380. 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 CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set?

CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set is a medical device that received FDA 510(k) clearance on 2020-07-20. The listed applicant is Codman & Shurtleff, Inc.. The 510(k) number is K193380.

When did CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set receive FDA 510(k) clearance?

CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set received FDA 510(k) clearance on 2020-07-20, under 510(k) number K193380.

Who is the listed applicant for CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set?

The FDA 510(k) record lists Codman & Shurtleff, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set?

The FDA product code for CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set is NRY.

其他以 Codman & Shurtleff, Inc. 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。

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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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