FDA 510(k)

AZUR 血管塞

K 號：K191680 · 2020-03-20

決定日期2020-03-20

產品代碼KRD

諮詢委員會履歷

決定相當於

器材摘要

AZUR Vascular Plug is the device name listed in this FDA 510(k) record. The listed applicant is MicroVention, Inc.. It received FDA 510(k) clearance on 2020-03-20 under 510(k) number K191680. 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 AZUR Vascular Plug?

AZUR Vascular Plug is a medical device that received FDA 510(k) clearance on 2020-03-20. The listed applicant is MicroVention, Inc.. The 510(k) number is K191680.

When did AZUR Vascular Plug receive FDA 510(k) clearance?

AZUR Vascular Plug received FDA 510(k) clearance on 2020-03-20, under 510(k) number K191680.

Who is the listed applicant for AZUR Vascular Plug?

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

What is the FDA product code for AZUR Vascular Plug?

The FDA product code for AZUR Vascular Plug is KRD.

其他以 MicroVention, 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。

K232542Wedge XL 輸送導管 K230775SOFIA EX 颅內支撐導管 K222694EmPro EPS (EP4514C-190, EP6514C-190)；Nanoparasol EPS (PNP4514C-190, PNP6514C-190)K222115ISAAC神經血管導航針管 K223050AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)K214024SOFIA 88 尿管

查看所有 24 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。