FDA 510(k)

D'Vill 引入器

K 號：K190974 · 2019-05-14

決定日期2019-05-14

產品代碼DYB

諮詢委員會履歷

決定相當於

器材摘要

D'Vill Introducer is the device name listed in this FDA 510(k) record. The listed applicant is NuMED, Inc.. It received FDA 510(k) clearance on 2019-05-14 under 510(k) number K190974. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the D'Vill Introducer?

D'Vill Introducer is a medical device that received FDA 510(k) clearance on 2019-05-14. The listed applicant is NuMED, Inc.. The 510(k) number is K190974.

When did D'Vill Introducer receive FDA 510(k) clearance?

D'Vill Introducer received FDA 510(k) clearance on 2019-05-14, under 510(k) number K190974.

Who is the listed applicant for D'Vill Introducer?

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

What is the FDA product code for D'Vill Introducer?

The FDA product code for D'Vill Introducer is DYB.

其他以 NuMED, 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。

K213915BIB支架置入導管 K211910Z-6 心房中隔穿刺針 K211134BIB支架置入導管 K171206D'Vill 引入器 K161451BIB支架置入導管 K160598REBOA 气球導管

查看所有 8 項裝置 →

相關器械（代碼：DYB）

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。

K253526NAMIC 扩張器及套管Medline Industries, LP K261529微穿刺套件 / 微穿刺接入套件 / 微穿刺導入器組 / 微導入器套件 / 微導入器套件（SIS05C）；微穿刺套件 / 微穿刺接入套件 / 微穿刺導入器組 / 微導入器套件 / 微導入器套件（IS01）；導入器套件 / 微導入器套件 / 導入器組 / 微導入器組 / 微導入器鞘組 / 導入器鞘組（NIS04）Hartman Medical Group, LLC K261242簡易導引Pendracare K261950健康線拆離導入器Health Line International Corporation K261492FieldFlex 經導鞘CenterPoint Systems, LLC K260606回聲大內徑導入鞘Echo Medical, LLC

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。