FDA 510(k)

路92醫療088進入系統，110公分

K 號：K200121 · 2020-04-18

決定日期2020-04-18

產品代碼QJP

諮詢委員會履歷

決定相當於

器材摘要

Route 92 Medical 088 Access System, 110 cm is the device name listed in this FDA 510(k) record. The listed applicant is Route 92 Medical, Inc.. It received FDA 510(k) clearance on 2020-04-18 under 510(k) number K200121. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Route 92 Medical 088 Access System, 110 cm?

Route 92 Medical 088 Access System, 110 cm is a medical device that received FDA 510(k) clearance on 2020-04-18. The listed applicant is Route 92 Medical, Inc.. The 510(k) number is K200121.

When did Route 92 Medical 088 Access System, 110 cm receive FDA 510(k) clearance?

Route 92 Medical 088 Access System, 110 cm received FDA 510(k) clearance on 2020-04-18, under 510(k) number K200121.

Who is the listed applicant for Route 92 Medical 088 Access System, 110 cm?

FDA 510(k) 記錄將 Route 92 Medical, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Route 92 Medical 088 Access System, 110 cm?

The FDA product code for Route 92 Medical 088 Access System, 110 cm is QJP.

其他以 Route 92 Medical, 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。

K260220路92醫療全長046進入系統 K24360192醫療HiPoint再灌流系統及吸引管路組 K2405298F 改良套管系統 K233329路92醫療全長054再灌流系統及吸引管路組 K231583路92醫療全長054進入系統 K223530路92醫療全長070再灌流系統及吸引管路組

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相關器械（代碼：QJP）

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。

K260220路92醫療全長046進入系統Route 92 Medical, Inc.K26227770 神經導引針管Piraeus Medical, Inc.K261176Zoom 4S 管針Imperative Care, Inc.K254071p17 XR 微导管Wallaby Medical K260199SLIM 微导管Balt USA, LLC K253901蟻蟻88 接通導管Perfuze, Ltd.

官方來源

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