FDA 510(k)

HRSpheres 狭小尺寸栓塊微膠球

K 號：K210562 · 2021-10-01

申請人Suzhou Hengrui Hongyuan Medical Co., Ltd.

決定日期2021-10-01

產品代碼KRD

諮詢委員會履歷

決定相當於

器材摘要

HRSpheres Narrow-Size Embolic Microspheres 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 2021-10-01 under 510(k) number K210562. The device is classified under product code KRD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the HRSpheres Narrow-Size Embolic Microspheres?

HRSpheres Narrow-Size Embolic Microspheres is a medical device that received FDA 510(k) clearance on 2021-10-01. The listed applicant is Suzhou Hengrui Hongyuan Medical Co., Ltd.. The 510(k) number is K210562.

When did HRSpheres Narrow-Size Embolic Microspheres receive FDA 510(k) clearance?

HRSpheres Narrow-Size Embolic Microspheres received FDA 510(k) clearance on 2021-10-01, under 510(k) number K210562.

Who is the listed applicant for HRSpheres Narrow-Size Embolic Microspheres?

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 HRSpheres Narrow-Size Embolic Microspheres?

The FDA product code for HRSpheres Narrow-Size Embolic Microspheres is KRD.

其他以 Suzhou Hengrui Hongyuan Medical Co., Ltd. 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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相關器械（代碼：KRD）

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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