FDA 510(k)

SafeCross 靜脈導管系統（4001）

K 號：K240600 · 2024-09-06

決定日期2024-09-06

產品代碼DYB

諮詢委員會履歷

決定相當於

器材摘要

SafeCross Vascular Introducer System (4001) is the device name listed in this FDA 510(k) record. The listed applicant is East End Medical I, LLC. It received FDA 510(k) clearance on 2024-09-06 under 510(k) number K240600. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SafeCross Vascular Introducer System (4001)?

SafeCross Vascular Introducer System (4001) is a medical device that received FDA 510(k) clearance on 2024-09-06. The listed applicant is East End Medical I, LLC. The 510(k) number is K240600.

When did SafeCross Vascular Introducer System (4001) receive FDA 510(k) clearance?

SafeCross Vascular Introducer System (4001) received FDA 510(k) clearance on 2024-09-06, under 510(k) number K240600.

Who is the listed applicant for SafeCross Vascular Introducer System (4001)?

The FDA 510(k) record lists East End Medical I, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SafeCross Vascular Introducer System (4001)?

The FDA product code for SafeCross Vascular Introducer System (4001) is DYB.

其他以 East End Medical I, LLC 為申請人之記錄

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K203459SafeCross 過隔膜穿刺及導管（TSP/I）系統

相關器械（代碼：DYB）

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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