FDA 510(k)

Paragon 8F 气球導管

K 號：K232437 · 2023-10-13

決定日期2023-10-13

產品代碼DQY

諮詢委員會履歷

決定相當於

器材摘要

Paragon 8F Balloon Guide Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Wallaby Medical. It received FDA 510(k) clearance on 2023-10-13 under 510(k) number K232437. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Paragon 8F Balloon Guide Catheter?

Paragon 8F Balloon Guide Catheter is a medical device that received FDA 510(k) clearance on 2023-10-13. The listed applicant is Wallaby Medical. The 510(k) number is K232437.

When did Paragon 8F Balloon Guide Catheter receive FDA 510(k) clearance?

Paragon 8F Balloon Guide Catheter received FDA 510(k) clearance on 2023-10-13, under 510(k) number K232437.

Who is the listed applicant for Paragon 8F Balloon Guide Catheter?

FDA 510(k) 記錄將 Wallaby Medical 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Paragon 8F Balloon Guide Catheter?

The FDA product code for Paragon 8F Balloon Guide Catheter is DQY.

其他以 Wallaby Medical 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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