FDA 510(k)

exGraft, exGraft碳ePTFE血管移植物

K 號：K180957 · 2018-08-21

決定日期2018-08-21

產品代碼DSY

諮詢委員會履歷

決定相當於

器材摘要

exGraft, exGraft Carbon ePTFE Vascular Grafts is the device name listed in this FDA 510(k) record. The listed applicant is Peca Labs. It received FDA 510(k) clearance on 2018-08-21 under 510(k) number K180957. 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 exGraft, exGraft Carbon ePTFE Vascular Grafts?

exGraft, exGraft Carbon ePTFE Vascular Grafts is a medical device that received FDA 510(k) clearance on 2018-08-21. The listed applicant is Peca Labs. The 510(k) number is K180957.

When did exGraft, exGraft Carbon ePTFE Vascular Grafts receive FDA 510(k) clearance?

exGraft, exGraft Carbon ePTFE Vascular Grafts received FDA 510(k) clearance on 2018-08-21, under 510(k) number K180957.

Who is the listed applicant for exGraft, exGraft Carbon ePTFE Vascular Grafts?

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

What is the FDA product code for exGraft, exGraft Carbon ePTFE Vascular Grafts?

The FDA product code for exGraft, exGraft Carbon ePTFE Vascular Grafts is DSY.

其他以 Peca Labs 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。

K221628exGraft, exGraft碳 K202471exGraft ePTFE血管移植物，exGraft碳ePTFE血管移植物 K183613exGraft, exGraft碳

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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