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FDA 510(k)

米勒-卡普心血管通氣導管

K 號:K200289 · 2021-01-28

決定日期2021-01-28
產品代碼DWF
諮詢委員會履歷
決定相當於

器材摘要

Michler-Kapp Cardiovascular Vent Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Kapp Surgical Instrument, Inc.. It received FDA 510(k) clearance on 2021-01-28 under 510(k) number K200289. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Michler-Kapp Cardiovascular Vent Catheter?

Michler-Kapp Cardiovascular Vent Catheter is a medical device that received FDA 510(k) clearance on 2021-01-28. The listed applicant is Kapp Surgical Instrument, Inc.. The 510(k) number is K200289.

When did Michler-Kapp Cardiovascular Vent Catheter receive FDA 510(k) clearance?

Michler-Kapp Cardiovascular Vent Catheter received FDA 510(k) clearance on 2021-01-28, under 510(k) number K200289.

Who is the listed applicant for Michler-Kapp Cardiovascular Vent Catheter?

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

What is the FDA product code for Michler-Kapp Cardiovascular Vent Catheter?

The FDA product code for Michler-Kapp Cardiovascular Vent Catheter is DWF.

相關臨床試驗

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相關器械(代碼:DWF)

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。

官方來源

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