FDA 510(k)

COREPASS 模組化微導管（FLEX）；COREPASS 模組化微導管（CONTROL）

K 號：K242588 · 2025-01-07

申請人OrbusNeich Medical (Shenzhen) Co., Ltd.

決定日期2025-01-07

產品代碼DQY

諮詢委員會履歷

決定相當於

器材摘要

COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL) is the device name listed in this FDA 510(k) record. The listed applicant is OrbusNeich Medical (Shenzhen) Co., Ltd.. It received FDA 510(k) clearance on 2025-01-07 under 510(k) number K242588. 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 COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL)?

COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL) is a medical device that received FDA 510(k) clearance on 2025-01-07. The listed applicant is OrbusNeich Medical (Shenzhen) Co., Ltd.. The 510(k) number is K242588.

When did COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL) receive FDA 510(k) clearance?

COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL) received FDA 510(k) clearance on 2025-01-07, under 510(k) number K242588.

Who is the listed applicant for COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL)?

FDA 510(k) 記錄將OrbusNeich Medical (Shenzhen) Co., Ltd. 列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL)?

The FDA product code for COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL) is DQY.

其他以 OrbusNeich Medical (Shenzhen) 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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