FDA 510(k)

Navi™ 非針式血液採集裝置 (VNC20500FG, VNC22500FG, VNC24500FG)

K 號：K244047 · 2025-05-23

決定日期2025-05-23

產品代碼JKA

諮詢委員會CH

決定相當於

器材摘要

Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG) is the device name listed in this FDA 510(k) record. The listed applicant is Venocare, Inc.. It received FDA 510(k) clearance on 2025-05-23 under 510(k) number K244047. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG)?

Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG) is a medical device that received FDA 510(k) clearance on 2025-05-23. The listed applicant is Venocare, Inc.. The 510(k) number is K244047.

When did Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG) receive FDA 510(k) clearance?

Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG) received FDA 510(k) clearance on 2025-05-23, under 510(k) number K244047.

Who is the listed applicant for Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG)?

FDA 510(k) 記錄將 Venocare, 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 Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG)?

The FDA product code for Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG) is JKA.

其他以 Venocare, 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。

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相關器械（代碼：JKA）

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。

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官方來源

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