FDA 510(k)

微导管及導絲系統

K 號：K212719 · 2022-04-11

申請人Suzhou Hengrui Hongyuan Medical Co., Ltd.

決定日期2022-04-11

產品代碼KRA

諮詢委員會履歷

決定相當於

器材摘要

Micro Catheter and Guidewire System is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Hengrui Hongyuan Medical Co., Ltd.. It received FDA 510(k) clearance on 2022-04-11 under 510(k) number K212719. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Micro Catheter and Guidewire System?

Micro Catheter and Guidewire System is a medical device that received FDA 510(k) clearance on 2022-04-11. The listed applicant is Suzhou Hengrui Hongyuan Medical Co., Ltd.. The 510(k) number is K212719.

When did Micro Catheter and Guidewire System receive FDA 510(k) clearance?

Micro Catheter and Guidewire System received FDA 510(k) clearance on 2022-04-11, under 510(k) number K212719.

Who is the listed applicant for Micro Catheter and Guidewire System?

The FDA 510(k) record lists Suzhou Hengrui Hongyuan Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Micro Catheter and Guidewire System?

The FDA product code for Micro Catheter and Guidewire System is KRA.

其他以 Suzhou Hengrui Hongyuan Medical Co., Ltd. 為申請人之記錄

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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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