FDA 510(k)

Gelseal血管移植物、Gelsoft血管移植物、Gelsoft Plus血管移植物

K 號：K162803 · 2017-07-14

決定日期2017-07-14

產品代碼DSY

諮詢委員會履歷

決定相當於

器材摘要

Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts is the device name listed in this FDA 510(k) record. The listed applicant is Vascutek, Ltd.. It received FDA 510(k) clearance on 2017-07-14 under 510(k) number K162803. 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 Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts?

Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts is a medical device that received FDA 510(k) clearance on 2017-07-14. The listed applicant is Vascutek, Ltd.. The 510(k) number is K162803.

When did Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts receive FDA 510(k) clearance?

Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts received FDA 510(k) clearance on 2017-07-14, under 510(k) number K162803.

Who is the listed applicant for Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts?

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

What is the FDA product code for Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts?

The FDA product code for Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts is DSY.

其他以 Vascutek, Ltd. 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。

K241550Gelweave™ 血管代用品 K241070Gelsoft™ Plus 靜脈代用品 K202703Vascutek Gelsoft Plus ERS 頸動脈移植管 K200955Vascutek Gelseal 补片，Vascutek Gelsoft 补片，Vascutek 薄壁頸動脈補片 K162794Gelweave 血管移植物

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

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