FDA 510(k)

橫跨血管RF穿隔針，橫跨血管連接線

K 號：K232852 · 2023-10-12

決定日期2023-10-12

產品代碼DXF

諮詢委員會履歷

決定相當於

器材摘要

Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable is the device name listed in this FDA 510(k) record. The listed applicant is Cross Vascular, Inc.. It received FDA 510(k) clearance on 2023-10-12 under 510(k) number K232852. The device is classified under product code DXF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable?

Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable is a medical device that received FDA 510(k) clearance on 2023-10-12. The listed applicant is Cross Vascular, Inc.. The 510(k) number is K232852.

When did Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable receive FDA 510(k) clearance?

Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable received FDA 510(k) clearance on 2023-10-12, under 510(k) number K232852.

Who is the listed applicant for Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable?

The FDA 510(k) record lists Cross Vascular, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable?

The FDA product code for Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable is DXF.

其他以 Cross Vascular, 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。

K232809橫向血管RF發生器及腳踏開關（選購配件）

相關器械（代碼：DXF）

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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