FDA 510(k)

BNLE通路導絲

K 號：K221390 · 2023-04-28

決定日期2023-04-28

產品代碼DQX

諮詢委員會履歷

決定相當於

器材摘要

BNLE Access Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Biomerics Nle. It received FDA 510(k) clearance on 2023-04-28 under 510(k) number K221390. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BNLE Access Guidewire?

BNLE Access Guidewire is a medical device that received FDA 510(k) clearance on 2023-04-28. The listed applicant is Biomerics Nle. The 510(k) number is K221390.

When did BNLE Access Guidewire receive FDA 510(k) clearance?

BNLE Access Guidewire received FDA 510(k) clearance on 2023-04-28, under 510(k) number K221390.

Who is the listed applicant for BNLE Access Guidewire?

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

What is the FDA product code for BNLE Access Guidewire?

The FDA product code for BNLE Access Guidewire is DQX.

其他以 Biomerics Nle 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。

K232662BNLE 水性包覆外周導絲

相關器械（代碼：DQX）

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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