FDA 510(k)

BOBBY 气球導管導引針

K 號：K261549 · 2026-06-09

申請人MicroVention, Inc., d/b/a Terumo Neuro

決定日期2026-06-09

產品代碼QJP

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., d/b/a Terumo Neuro. It received FDA 510(k) clearance on 2026-06-09 under 510(k) number K261549. 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 BOBBY Balloon Guide Catheter?

BOBBY Balloon Guide Catheter is a medical device that received FDA 510(k) clearance on 2026-06-09. The listed applicant is MicroVention, Inc., d/b/a Terumo Neuro. The 510(k) number is K261549.

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

BOBBY Balloon Guide Catheter received FDA 510(k) clearance on 2026-06-09, under 510(k) number K261549.

Who is the listed applicant for BOBBY Balloon Guide Catheter?

FDA 510(k) 記錄中將 MicroVention, Inc.（商號為 Terumo Neuro）列為申請人。這並不單獨確立設備製造商。

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

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

其他以 MicroVention, Inc., d/b/a Terumo Neuro 為申請人之記錄

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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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