FDA 510(k)

ACISTCVi® 對比劑輸送系統

K 號：K171646 · 2018-02-16

決定日期2018-02-16

產品代碼DXT

諮詢委員會履歷

決定相當於

器材摘要

ACISTCVi® Contrast Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Acist Medical Systems, Inc.. It received FDA 510(k) clearance on 2018-02-16 under 510(k) number K171646. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ACISTCVi® Contrast Delivery System?

ACISTCVi® Contrast Delivery System is a medical device that received FDA 510(k) clearance on 2018-02-16. The listed applicant is Acist Medical Systems, Inc.. The 510(k) number is K171646.

When did ACISTCVi® Contrast Delivery System receive FDA 510(k) clearance?

ACISTCVi® Contrast Delivery System received FDA 510(k) clearance on 2018-02-16, under 510(k) number K171646.

Who is the listed applicant for ACISTCVi® Contrast Delivery System?

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

What is the FDA product code for ACISTCVi® Contrast Delivery System?

The FDA product code for ACISTCVi® Contrast Delivery System is DXT.

其他以 Acist Medical Systems, 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：DXT）

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。

K252652用於高壓注射器之拋棄式注射器及配件 (900103T); 用於高壓注射器之拋棄式注射器及配件 (900103H); 用於高壓注射器之拋棄式注射器及配件 (801800H); 用於高壓注射器之拋棄式注射器及配件 (800099T); 用於高壓注射器之拋棄式注射器及配件 (800099H); 用於高壓注射器之拋棄式注射器及配件 (800096T); 用於高壓注射器之拋棄式注射器及配件 (800096H); 拋棄式注射器Fortis Biosolutions Company Limited K252638VeraPro S100 多用針筒 (018808)；VeraPro S100 LV1 低濃度單次使用針筒 (018811)；VeraPro AMT 自動分配器和傳感器 (018814)；VeraPro AngioTouch FLX165 手控器套件 (018806)；VeraPro AngioTouch HiFi165 手控器套件 (018804)Acist Medical Systems, Inc.K252653ACIST Pro 诊断系統 (019304)；處理單元床架；AngioTouch 模組；ACIST Pro 車；單晶體傳感器電纜；三晶體傳感器電纜Acist Medical Systems, Inc.K253048高壓針筒；壓力連接管；快速填充管；針頭；轉移管Shenzhen Maiwei Biotech Co., Ltd.K251788延伸管Zhuhai DR Medical Instruments Co., Ltd.K252891MEDRAD MRXperion MR注射系統及MR注射系統針筒組；MEDRAD ISI2 模組（ISI2）Bayer Medical Care, Inc.

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