FDA 510(k)

雪倫內支氣管管

K 號：K180253 · 2018-11-02

決定日期2018-11-02

產品代碼CBI

諮詢委員會AN

決定相當於

器材摘要

Sheridan Endobronchial Tubes is the device name listed in this FDA 510(k) record. The listed applicant is Teleflex Medical. It received FDA 510(k) clearance on 2018-11-02 under 510(k) number K180253. The device is classified under product code CBI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Sheridan Endobronchial Tubes?

Sheridan Endobronchial Tubes is a medical device that received FDA 510(k) clearance on 2018-11-02. The listed applicant is Teleflex Medical. The 510(k) number is K180253.

When did Sheridan Endobronchial Tubes receive FDA 510(k) clearance?

Sheridan Endobronchial Tubes received FDA 510(k) clearance on 2018-11-02, under 510(k) number K180253.

Who is the listed applicant for Sheridan Endobronchial Tubes?

FDA 510(k) 記錄將Teleflex Medical列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for Sheridan Endobronchial Tubes?

The FDA product code for Sheridan Endobronchial Tubes is CBI.

其他以 Teleflex Medical 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。

K261418Liquick X-treme, Liquick X-treme Plus K251054Hem-o-lok™ 紫色加™ 大型聚合物結合夾 K242495LMA Fastrach ETT SU K243553QuikClot Control+ 體內止血設備 K241784Arrow® Nitinol Wire K233713Pilling 氣管切開管

查看所有 21 項裝置 →

相關器械（代碼：CBI）

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

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。