FDA 510(k)

Gelsoft™ Plus 靜脈代用品

K 號：K241070 · 2024-11-15

決定日期2024-11-15

產品代碼DSY

諮詢委員會履歷

決定相當於

器材摘要

Gelsoft™ Plus Vascular Prostheses is the device name listed in this FDA 510(k) record. The listed applicant is Vascutek, Ltd.. It received FDA 510(k) clearance on 2024-11-15 under 510(k) number K241070. 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 Gelsoft™ Plus Vascular Prostheses?

Gelsoft™ Plus Vascular Prostheses is a medical device that received FDA 510(k) clearance on 2024-11-15. The listed applicant is Vascutek, Ltd.. The 510(k) number is K241070.

When did Gelsoft™ Plus Vascular Prostheses receive FDA 510(k) clearance?

Gelsoft™ Plus Vascular Prostheses received FDA 510(k) clearance on 2024-11-15, under 510(k) number K241070.

Who is the listed applicant for Gelsoft™ Plus Vascular Prostheses?

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 Gelsoft™ Plus Vascular Prostheses?

The FDA product code for Gelsoft™ Plus Vascular Prostheses 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 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 K162803Gelseal血管移植物、Gelsoft血管移植物、Gelsoft Plus血管移植物 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.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.K233783exGraft ePTFE血管移植物，exGraft碳ePTFE血管移植物Peca Labs, Inc.

官方來源

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