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FDA 510(k)

BOSS 气球導管導引針

K 號：K200910 · 2020-05-02

申請人Marblehead Medical
決定日期2020-05-02
產品代碼QJP
諮詢委員會履歷
決定相當於

器材摘要

BOSS Balloon Guide Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Marblehead Medical. It received FDA 510(k) clearance on 2020-05-02 under 510(k) number K200910. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BOSS Balloon Guide Catheter?

BOSS Balloon Guide Catheter is a medical device that received FDA 510(k) clearance on 2020-05-02. The listed applicant is Marblehead Medical. The 510(k) number is K200910.

When did BOSS Balloon Guide Catheter receive FDA 510(k) clearance?

BOSS Balloon Guide Catheter received FDA 510(k) clearance on 2020-05-02, under 510(k) number K200910.

Who is the listed applicant for BOSS Balloon Guide Catheter?

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

What is the FDA product code for BOSS Balloon Guide Catheter?

The FDA product code for BOSS Balloon Guide Catheter is QJP.

相關臨床試驗

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相關器械（代碼：QJP）

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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