FDA 510(k)

pREBOA-PRO 管針

K 號：K200459 · 2020-06-03

決定日期2020-06-03

產品代碼MJN

諮詢委員會履歷

決定相當於

器材摘要

pREBOA-PRO 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 2020-06-03 under 510(k) number K200459. 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 pREBOA-PRO Catheter?

pREBOA-PRO Catheter is a medical device that received FDA 510(k) clearance on 2020-06-03. The listed applicant is Prytime Medical Devices, Inc.. The 510(k) number is K200459.

When did pREBOA-PRO Catheter receive FDA 510(k) clearance?

pREBOA-PRO Catheter received FDA 510(k) clearance on 2020-06-03, under 510(k) number K200459.

Who is the listed applicant for pREBOA-PRO 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 pREBOA-PRO Catheter?

The FDA product code for pREBOA-PRO 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 K193440ER-REBOA PLUS 緩針管 K172790ER-REBOA 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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