FDA 510(k)

索爾-保護TM XtraThin 安全拉環血液收集套件

K 號：K250907 · 2025-04-30

決定日期2025-04-30

產品代碼JKA

諮詢委員會CH

決定相當於

器材摘要

Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set is the device name listed in this FDA 510(k) record. The listed applicant is Sol-Millennium Medical, Inc.. It received FDA 510(k) clearance on 2025-04-30 under 510(k) number K250907. 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 Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set?

Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set is a medical device that received FDA 510(k) clearance on 2025-04-30. The listed applicant is Sol-Millennium Medical, Inc.. The 510(k) number is K250907.

When did Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set receive FDA 510(k) clearance?

Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set received FDA 510(k) clearance on 2025-04-30, under 510(k) number K250907.

Who is the listed applicant for Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set?

FDA 510(k) 記錄將 Sol-Millennium Medical, Inc. 列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set?

The FDA product code for Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set is JKA.

其他以 Sol-Millennium Medical, 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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