FDA 510(k)

Trio-CT 三腔管心导管

K 號：K183219 · 2019-06-14

申請人Medical Components, Inc. (dba MedComp)

決定日期2019-06-14

產品代碼NIE

諮詢委員會GU

決定Unknown

器材摘要

Trio-CT 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 2019-06-14 under 510(k) number K183219. 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 Trio-CT Triple Lumen Catheter?

Trio-CT Triple Lumen Catheter is a medical device that received FDA 510(k) clearance on 2019-06-14. The listed applicant is Medical Components, Inc. (dba MedComp). The 510(k) number is K183219.

When did Trio-CT Triple Lumen Catheter receive FDA 510(k) clearance?

Trio-CT Triple Lumen Catheter received FDA 510(k) clearance on 2019-06-14, under 510(k) number K183219.

Who is the listed applicant for Trio-CT 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 Trio-CT Triple Lumen Catheter?

The FDA product code for Trio-CT 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 K18117512F 三通三腔導管 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 K18117512F 三通三腔導管Medical Components, Inc. (dba MedComp)

官方來源

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