FDA 510(k)

膠珠

K 號：K171946 · 2017-10-25

決定日期2017-10-25

產品代碼KRD

諮詢委員會履歷

決定相當於

器材摘要

Gel-Bead is the device name listed in this FDA 510(k) record. The listed applicant is Vascular Solutions, Inc.. It received FDA 510(k) clearance on 2017-10-25 under 510(k) number K171946. The device is classified under product code KRD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Gel-Bead?

Gel-Bead is a medical device that received FDA 510(k) clearance on 2017-10-25. The listed applicant is Vascular Solutions, Inc.. The 510(k) number is K171946.

When did Gel-Bead receive FDA 510(k) clearance?

Gel-Bead received FDA 510(k) clearance on 2017-10-25, under 510(k) number K171946.

Who is the listed applicant for Gel-Bead?

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

What is the FDA product code for Gel-Bead?

The FDA product code for Gel-Bead is KRD.

其他以 Vascular Solutions, 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。

K182232奧克塔恩機械血栓切除系統 K181647Bandit 導絲 K180913VSI 微導入套件 K180088捕獲線導管 K180128戰士14導絲 K173891膠珠（600-800微米）- 1毫升球體體積，膠珠（600-800微米）- 2毫升球體體積

查看所有 19 項裝置 →

相關器械（代碼：KRD）

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。

K252812UniPearls® 遮斷微膠球Suzhou Haowei Medical Technology Co., Ltd.K261488OBSIDIO 可調適性栓塊Boston Scientific Corporation K261866Concerto Versa™ 可拆式線圈Medtronic, Inc.K260635HARBOR 閉塞設備Nuvascular, Inc.K260508LOBO血管栓塞系統Okami Medical, Inc.K253511Concerto Versa™ 可拆式線圈Medtronic, Inc.

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。