FDA 510(k)

VersaD 輸送導管

K 號：K251372 · 2025-10-24

決定日期2025-10-24

產品代碼QJP

諮詢委員會履歷

決定相當於

器材摘要

VersaD Delivery Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Unity Medical, Inc.. It received FDA 510(k) clearance on 2025-10-24 under 510(k) number K251372. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VersaD Delivery Catheter?

VersaD Delivery Catheter is a medical device that received FDA 510(k) clearance on 2025-10-24. The listed applicant is Unity Medical, Inc.. The 510(k) number is K251372.

When did VersaD Delivery Catheter receive FDA 510(k) clearance?

VersaD Delivery Catheter received FDA 510(k) clearance on 2025-10-24, under 510(k) number K251372.

Who is the listed applicant for VersaD Delivery Catheter?

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

What is the FDA product code for VersaD Delivery Catheter?

The FDA product code for VersaD Delivery Catheter is QJP.

其他以 Unity Medical, Inc. 為申請人之記錄

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K242051VersaD 輸送導管

相關器械（代碼：QJP）

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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