FDA 510(k)

融合血管移植物

K 號：K153523 · 2016-02-16

決定日期2016-02-16

產品代碼DSY

諮詢委員會履歷

決定相當於

器材摘要

FUSION Vascular Graft is the device name listed in this FDA 510(k) record. The listed applicant is Maquet Cardiovascular, LLC. It received FDA 510(k) clearance on 2016-02-16 under 510(k) number K153523. The device is classified under product code DSY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FUSION Vascular Graft?

FUSION Vascular Graft is a medical device that received FDA 510(k) clearance on 2016-02-16. The listed applicant is Maquet Cardiovascular, LLC. The 510(k) number is K153523.

When did FUSION Vascular Graft receive FDA 510(k) clearance?

FUSION Vascular Graft received FDA 510(k) clearance on 2016-02-16, under 510(k) number K153523.

Who is the listed applicant for FUSION Vascular Graft?

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

What is the FDA product code for FUSION Vascular Graft?

The FDA product code for FUSION Vascular Graft is DSY.

其他以 Maquet Cardiovascular, LLC 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。

K252445Fusion Bioline 血管移植物 K251238Vasoview Hemopro 3內視鏡血管採集系統（VH-6000）；Vasoview Hemopro 3內視鏡血管採集系統搭配Vasoshield（VH-6001）；Vasoview Hemopro 3電源供應器（VH-6010）K243918Vasoview Hemopro 3 電源供應器 K233879Vasoview Hemopro 3內視鏡血管採集系統（VH-6000），Vasoview Hemopro 3內視鏡血管採集系統搭配Vasoshield（VH-6001），Vasoview Hemopro 3電源轉接器（VH-6020）K1919307 mm 延長長度內視鏡 K191947VASOVIEW HEMOPRO 延長線，VASOVIEW HEMOPRO 2 延長線，雙極延長線，固定距離，活動回電線

查看所有 8 項裝置 →

相關器械（代碼：DSY）

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。

K252445Fusion Bioline 血管移植物Maquet Cardiovascular, LLC K252277螺旋層流™血管動靜脈移植片 (AV0645)Vascular Flow Technologies Limited K241550Gelweave™ 血管代用品Vascutek, Ltd.K241070Gelsoft™ Plus 靜脈代用品Vascutek, Ltd.K231972Advanta VXT 腹腔內血管移植物，Flixene 腹腔內血管移植物Atrium Medical Corporation K240083GORE® PROPAATEN® 頸動脈移植物W. L. Gore & Associates, 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。