FDA 510(k)

SENDERO 微导管

K 號：K240384 · 2024-03-08

決定日期2024-03-08

產品代碼DQY

諮詢委員會履歷

決定相當於

器材摘要

SENDERO Microcatheter is the device name listed in this FDA 510(k) record. The listed applicant is Okami Medical, Inc.. It received FDA 510(k) clearance on 2024-03-08 under 510(k) number K240384. 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 SENDERO Microcatheter?

SENDERO Microcatheter is a medical device that received FDA 510(k) clearance on 2024-03-08. The listed applicant is Okami Medical, Inc.. The 510(k) number is K240384.

When did SENDERO Microcatheter receive FDA 510(k) clearance?

SENDERO Microcatheter received FDA 510(k) clearance on 2024-03-08, under 510(k) number K240384.

Who is the listed applicant for SENDERO Microcatheter?

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

What is the FDA product code for SENDERO Microcatheter?

The FDA product code for SENDERO Microcatheter is DQY.

其他以 Okami Medical, Inc. 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。

K260508LOBO血管栓塞系統 K242644SENDERO MAX 輸送導管 K231600SENDERO 微导管

相關器械（代碼：DQY）

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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