FDA 510(k)

IRRAflow 管腔導管，IRRAflow 管道組，IRRAflow 控制單元

K 號：K200807 · 2020-04-29

決定日期2020-04-29

產品代碼JXG

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit is the device name listed in this FDA 510(k) record. The listed applicant is Irras USA, Inc.. It received FDA 510(k) clearance on 2020-04-29 under 510(k) number K200807. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit?

IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit is a medical device that received FDA 510(k) clearance on 2020-04-29. The listed applicant is Irras USA, Inc.. The 510(k) number is K200807.

When did IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit receive FDA 510(k) clearance?

IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit received FDA 510(k) clearance on 2020-04-29, under 510(k) number K200807.

Who is the listed applicant for IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit?

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

What is the FDA product code for IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit?

The FDA product code for IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit is JXG.

其他以 Irras USA, Inc. 為申請人之記錄

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K231664IRRAflow 活動濾液交換系統 (AFES)

相關器械（代碼：JXG）

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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官方來源

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