FDA 510(k)

12F 三通三腔導管

K 號：K181175 · 2018-07-05

申請人Medical Components, Inc. (dba MedComp)

決定日期2018-07-05

產品代碼NIE

諮詢委員會GU

決定Unknown

器材摘要

12F Tri-Flow Triple Lumen Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Medical Components, Inc. (dba MedComp). It received FDA 510(k) clearance on 2018-07-05 under 510(k) number K181175. The device is classified under product code NIE. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

常見問題

What is the 12F Tri-Flow Triple Lumen Catheter?

12F Tri-Flow Triple Lumen Catheter is a medical device that received FDA 510(k) clearance on 2018-07-05. The listed applicant is Medical Components, Inc. (dba MedComp). The 510(k) number is K181175.

When did 12F Tri-Flow Triple Lumen Catheter receive FDA 510(k) clearance?

12F Tri-Flow Triple Lumen Catheter received FDA 510(k) clearance on 2018-07-05, under 510(k) number K181175.

Who is the listed applicant for 12F Tri-Flow Triple Lumen Catheter?

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

What is the FDA product code for 12F Tri-Flow Triple Lumen Catheter?

The FDA product code for 12F Tri-Flow Triple Lumen Catheter is NIE.

其他以 Medical Components, Inc. (dba MedComp) 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。

K232945Trio-CT® 三腔管心臟內科導管配曲式延伸管 K202176Symetrex LTHD 穿刺管，附側孔的 Symetrex LTHD 穿刺管 K192807雙向流側側雙腔導管 K183219Trio-CT 三腔管心导管 K17366715.5F X 19 cm Symetrex 長期血液透析導管帶側孔，15.5F X 23 cm Symetrex 長期血液透析導管帶側孔，15.5F X 28 cm Symetrex 長期血液透析導管帶側孔，15.5F X 33 cm Symetrex 長期血液透析導管帶側孔，15.5F X 37 cm Symetrex 長期血液透析導管帶側孔 K180567C3波系統

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相關器械（代碼：NIE）

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。

K232945Trio-CT® 三腔管心臟內科導管配曲式延伸管Medical Components, Inc. (dba MedComp)K222170功率急性三腔血液透析导管Health Line International Corporation K183219Trio-CT 三腔管心导管Medical Components, Inc. (dba MedComp)

官方來源

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