橋接加壓氣球（590-002）
K 號：K251358 · 2025-06-24
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器材摘要
Bridge Plus Occlusion Balloon (590-002) is the device name listed in this FDA 510(k) record. The listed applicant is Philips Image Guided Therapy Devices. It received FDA 510(k) clearance on 2025-06-24 under 510(k) number K251358. The device is classified under product code MJN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Bridge Plus Occlusion Balloon (590-002)?
Bridge Plus Occlusion Balloon (590-002) is a medical device that received FDA 510(k) clearance on 2025-06-24. The listed applicant is Philips Image Guided Therapy Devices. The 510(k) number is K251358.
When did Bridge Plus Occlusion Balloon (590-002) receive FDA 510(k) clearance?
Bridge Plus Occlusion Balloon (590-002) received FDA 510(k) clearance on 2025-06-24, under 510(k) number K251358.
Who is the listed applicant for Bridge Plus Occlusion Balloon (590-002)?
The FDA 510(k) record lists Philips Image Guided Therapy Devices as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Bridge Plus Occlusion Balloon (590-002)?
The FDA product code for Bridge Plus Occlusion Balloon (590-002) is MJN.
相關臨床試驗
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相關器械（代碼：MJN）
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。
官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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