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FDA 510(k)

TAVIPILOT

K 號：K243884 · 2025-07-07

申請人Caranx Medical
決定日期2025-07-07
產品代碼OWB
諮詢委員會RA
決定相當於

器材摘要

TAVIPILOT is the device name listed in this FDA 510(k) record. The listed applicant is Caranx Medical. It received FDA 510(k) clearance on 2025-07-07 under 510(k) number K243884. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TAVIPILOT?

TAVIPILOT is a medical device that received FDA 510(k) clearance on 2025-07-07. The listed applicant is Caranx Medical. The 510(k) number is K243884.

When did TAVIPILOT receive FDA 510(k) clearance?

TAVIPILOT received FDA 510(k) clearance on 2025-07-07, under 510(k) number K243884.

Who is the listed applicant for TAVIPILOT?

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

What is the FDA product code for TAVIPILOT?

The FDA product code for TAVIPILOT is OWB.

相關臨床試驗

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。

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：OWB）

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。

K253726uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.K261413EXTRON 3;EXTRON 6DRTECH CorporationK254205Zenition 30Philips Medical Systems Nederland B.V.K260607防護系統（西門子 30x40）Radiaction , Ltd.K253670SmartCT (R3.0 (L10))Philips Medical Systems B.V.K252735C-beamPulmera, Inc.

官方來源

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