FDA 510(k)

LC珠 LUMI

K 號：K162373 · 2016-12-16

決定日期2016-12-16

產品代碼KRD

諮詢委員會履歷

決定相當於

器材摘要

LC Bead LUMI is the device name listed in this FDA 510(k) record. The listed applicant is Biocompatibles UK Limited. It received FDA 510(k) clearance on 2016-12-16 under 510(k) number K162373. 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 LC Bead LUMI?

LC Bead LUMI is a medical device that received FDA 510(k) clearance on 2016-12-16. The listed applicant is Biocompatibles UK Limited. The 510(k) number is K162373.

When did LC Bead LUMI receive FDA 510(k) clearance?

LC Bead LUMI received FDA 510(k) clearance on 2016-12-16, under 510(k) number K162373.

Who is the listed applicant for LC Bead LUMI?

The FDA 510(k) record lists Biocompatibles UK Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LC Bead LUMI?

The FDA product code for LC Bead LUMI is KRD.

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。