FDA 510(k)

ER-REBOA 緩針管

K 號：K172790 · 2017-11-08

決定日期2017-11-08

產品代碼MJN

諮詢委員會履歷

決定相當於

器材摘要

ER-REBOA Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Prytime Medical Devices, Inc.. It received FDA 510(k) clearance on 2017-11-08 under 510(k) number K172790. The device is classified under product code MJN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ER-REBOA Catheter?

ER-REBOA Catheter is a medical device that received FDA 510(k) clearance on 2017-11-08. The listed applicant is Prytime Medical Devices, Inc.. The 510(k) number is K172790.

When did ER-REBOA Catheter receive FDA 510(k) clearance?

ER-REBOA Catheter received FDA 510(k) clearance on 2017-11-08, under 510(k) number K172790.

Who is the listed applicant for ER-REBOA Catheter?

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

What is the FDA product code for ER-REBOA Catheter?

The FDA product code for ER-REBOA Catheter is MJN.

其他以 Prytime Medical Devices, 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。

K243795pREBOA-PRO 管針 K200459pREBOA-PRO 管針 K193440ER-REBOA PLUS 緩針管 K170411ER-REBOA 緩針管

相關器械（代碼：MJN）

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。

K243795pREBOA-PRO 管針Prytime Medical Devices, Inc.K251358橋接加壓氣球（590-002）Philips Image Guided Therapy Devices K221294preCARDIA 閉塞系統Abiomed, Inc.K214060標誌性REBOA導管Zien Medical Technologies, Inc.K211610福吉蒂塞鎖針管Edwards Lifesciences, LLC K212324RenovoCathRenovorx, Inc.

官方來源

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