FDA 510(k)

SafeCross 過隔膜穿刺及導管（TSP/I）系統

K 號：K203459 · 2021-07-06

決定日期2021-07-06

產品代碼DYB

諮詢委員會履歷

決定相當於

器材摘要

SafeCross Transseptal Puncture and Introducer (TSP/I) System 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 2021-07-06 under 510(k) number K203459. 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 Transseptal Puncture and Introducer (TSP/I) System?

SafeCross Transseptal Puncture and Introducer (TSP/I) System is a medical device that received FDA 510(k) clearance on 2021-07-06. The listed applicant is East End Medical I, LLC. The 510(k) number is K203459.

When did SafeCross Transseptal Puncture and Introducer (TSP/I) System receive FDA 510(k) clearance?

SafeCross Transseptal Puncture and Introducer (TSP/I) System received FDA 510(k) clearance on 2021-07-06, under 510(k) number K203459.

Who is the listed applicant for SafeCross Transseptal Puncture and Introducer (TSP/I) System?

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 Transseptal Puncture and Introducer (TSP/I) System?

The FDA product code for SafeCross Transseptal Puncture and Introducer (TSP/I) System is DYB.

其他以 East End Medical I, LLC 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。

K240600SafeCross 靜脈導管系統（4001）

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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