FDA 510(k)

BOBBY 气球導管導引針

K 號：K193607 · 2020-07-21

決定日期2020-07-21

產品代碼DQY

諮詢委員會履歷

決定相當於

器材摘要

BOBBY Balloon Guide Catheter is the device name listed in this FDA 510(k) record. The listed applicant is MicroVention, Inc.. It received FDA 510(k) clearance on 2020-07-21 under 510(k) number K193607. 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 BOBBY Balloon Guide Catheter?

BOBBY Balloon Guide Catheter is a medical device that received FDA 510(k) clearance on 2020-07-21. The listed applicant is MicroVention, Inc.. The 510(k) number is K193607.

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

BOBBY Balloon Guide Catheter received FDA 510(k) clearance on 2020-07-21, under 510(k) number K193607.

Who is the listed applicant for BOBBY Balloon Guide Catheter?

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

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

The FDA product code for BOBBY Balloon Guide Catheter is DQY.

其他以 MicroVention, Inc. 為申請人之記錄

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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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