FDA 510(k)

V-DAC 穿刺針

K 號：K251097 · 2026-01-06

決定日期2026-01-06

產品代碼QJP

諮詢委員會履歷

決定相當於

器材摘要

V-DAC Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Vesalio, Inc.. It received FDA 510(k) clearance on 2026-01-06 under 510(k) number K251097. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the V-DAC Catheter?

V-DAC Catheter is a medical device that received FDA 510(k) clearance on 2026-01-06. The listed applicant is Vesalio, Inc.. The 510(k) number is K251097.

When did V-DAC Catheter receive FDA 510(k) clearance?

V-DAC Catheter received FDA 510(k) clearance on 2026-01-06, under 510(k) number K251097.

Who is the listed applicant for V-DAC Catheter?

FDA 510(k) 記錄將 Vesalio, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for V-DAC Catheter?

The FDA product code for V-DAC Catheter is QJP.

其他以 Vesalio, 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。

K254211pVasc Net 體內機械血栓切除裝置 K253407NeVa 靜脈血栓切除裝置 K251006NeVasc 吸引系統 K251312維薩利周邊系統

相關器械（代碼：QJP）

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。

K260220路92醫療全長046進入系統Route 92 Medical, Inc.K26227770 神經導引針管Piraeus Medical, Inc.K261176Zoom 4S 管針Imperative Care, Inc.K254071p17 XR 微导管Wallaby Medical K260199SLIM 微导管Balt USA, LLC K253901蟻蟻88 接通導管Perfuze, Ltd.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。