FDA 510(k)

ICHOR 7F 鋸切除系統 (ICH-7F)

K 號：K233917 · 2024-07-18

申請人Ichor

決定日期2024-07-18

產品代碼QEW

諮詢委員會履歷

決定相當於

器材摘要

ICHOR 7F Embolectomy System (ICH-7F) is the device name listed in this FDA 510(k) record. The listed applicant is Ichor. It received FDA 510(k) clearance on 2024-07-18 under 510(k) number K233917. The device is classified under product code QEW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ICHOR 7F Embolectomy System (ICH-7F)?

ICHOR 7F Embolectomy System (ICH-7F) is a medical device that received FDA 510(k) clearance on 2024-07-18. The listed applicant is Ichor. The 510(k) number is K233917.

When did ICHOR 7F Embolectomy System (ICH-7F) receive FDA 510(k) clearance?

ICHOR 7F Embolectomy System (ICH-7F) received FDA 510(k) clearance on 2024-07-18, under 510(k) number K233917.

Who is the listed applicant for ICHOR 7F Embolectomy System (ICH-7F)?

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

What is the FDA product code for ICHOR 7F Embolectomy System (ICH-7F)?

The FDA product code for ICHOR 7F Embolectomy System (ICH-7F) is QEW.

其他以 Ichor 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。

K230743ICHOR 14F 靈管切除系統

相關器械（代碼：QEW）

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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