FDA 510(k)

GORE® PROPAATEN® 頸動脈移植物

K 號：K232312 · 2024-01-09

決定日期2024-01-09

產品代碼DSY

諮詢委員會履歷

決定相當於

器材摘要

GORE® PROPATEN® Vascular Graft is the device name listed in this FDA 510(k) record. The listed applicant is W. L. Gore & Associates, Inc.. It received FDA 510(k) clearance on 2024-01-09 under 510(k) number K232312. 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 GORE® PROPATEN® Vascular Graft?

GORE® PROPATEN® Vascular Graft is a medical device that received FDA 510(k) clearance on 2024-01-09. The listed applicant is W. L. Gore & Associates, Inc.. The 510(k) number is K232312.

When did GORE® PROPATEN® Vascular Graft receive FDA 510(k) clearance?

GORE® PROPATEN® Vascular Graft received FDA 510(k) clearance on 2024-01-09, under 510(k) number K232312.

Who is the listed applicant for GORE® PROPATEN® Vascular Graft?

The FDA 510(k) record lists W. L. Gore & Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GORE® PROPATEN® Vascular Graft?

The FDA product code for GORE® PROPATEN® Vascular Graft is DSY.

其他以 W. L. Gore & Associates, 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。

K250410GORE® 三葉球囊心导管 K240083GORE® PROPAATEN® 頸動脈移植物 K233551GORE® ACUSEAL 頸動脈移植管 K231505GORE® ACUSEAL 頸動脈移植管 K222919GORE® ENFORM 生物材質 K191773GORE BIO-A 組織強化劑

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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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