FDA 510(k)

路92醫療全長070進入系統

K 號：K222743 · 2022-10-04

決定日期2022-10-04

產品代碼QJP

諮詢委員會履歷

決定相當於

器材摘要

Route 92 Medical Full Length 070 Access System 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 2022-10-04 under 510(k) number K222743. 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 Full Length 070 Access System?

Route 92 Medical Full Length 070 Access System is a medical device that received FDA 510(k) clearance on 2022-10-04. The listed applicant is Route 92 Medical, Inc.. The 510(k) number is K222743.

When did Route 92 Medical Full Length 070 Access System receive FDA 510(k) clearance?

Route 92 Medical Full Length 070 Access System received FDA 510(k) clearance on 2022-10-04, under 510(k) number K222743.

Who is the listed applicant for Route 92 Medical Full Length 070 Access System?

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 Full Length 070 Access System?

The FDA product code for Route 92 Medical Full Length 070 Access System 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

查看所有 14 項裝置 →

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

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。