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FDA 510(k)

螺旋層流™血管動靜脈移植片 (AV0645)

K 號：K252277 · 2025-10-20

申請人Vascular Flow Technologies Limited
決定日期2025-10-20
產品代碼DSY
諮詢委員會履歷
決定相當於

器材摘要

Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645) is the device name listed in this FDA 510(k) record. The listed applicant is Vascular Flow Technologies Limited. It received FDA 510(k) clearance on 2025-10-20 under 510(k) number K252277. 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 Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645)?

Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645) is a medical device that received FDA 510(k) clearance on 2025-10-20. The listed applicant is Vascular Flow Technologies Limited. The 510(k) number is K252277.

When did Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645) receive FDA 510(k) clearance?

Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645) received FDA 510(k) clearance on 2025-10-20, under 510(k) number K252277.

Who is the listed applicant for Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645)?

The FDA 510(k) record lists Vascular Flow Technologies Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645)?

The FDA product code for Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645) is DSY.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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, LLCK241550Gelweave™ 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 CorporationK240083GORE® 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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