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FDA 510(k)

PG Pro 微导管

K 號：K192625 · 2019-11-21

申請人MicroVention, Inc. A TERUMO Group Company
決定日期2019-11-21
產品代碼DQY
諮詢委員會履歷
決定相當於

器材摘要

PG Pro Microcatheter is the device name listed in this FDA 510(k) record. The listed applicant is MicroVention, Inc. A TERUMO Group Company. It received FDA 510(k) clearance on 2019-11-21 under 510(k) number K192625. 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 PG Pro Microcatheter?

PG Pro Microcatheter is a medical device that received FDA 510(k) clearance on 2019-11-21. The listed applicant is MicroVention, Inc. A TERUMO Group Company. The 510(k) number is K192625.

When did PG Pro Microcatheter receive FDA 510(k) clearance?

PG Pro Microcatheter received FDA 510(k) clearance on 2019-11-21, under 510(k) number K192625.

Who is the listed applicant for PG Pro Microcatheter?

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

What is the FDA product code for PG Pro Microcatheter?

The FDA product code for PG Pro Microcatheter is DQY.

相關臨床試驗

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NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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。

K262817CrossFAST整合式微导管先進輸送系統Vantis Vascular, Inc.K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift 管針Alembic, LLCK262240SSPC NXT 輸送導管CenterPoint Systems, LLCK261766CPS 定位器 3D Plus 輸送导管CenterPoint Systems, LLCK261825Amplatzer TorqVue LP 運送系統; Amplatzer TorqVue LP 穿刺管Abbott

官方來源

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