內腔血流斷裂設備
PMA 核准號：P170032 · 2026-05-28
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決定日期2026-05-28
PMA 編號P170032
產品代碼OPR
器械分類3 類
醫療專科U
諮詢委員會NE
(請提供完整的英文描述，以便進行翻譯。)
器材摘要
Intrasaccular Flow Disruption Device is the device name listed in this FDA 510(k) record. The listed applicant is MicroVention, Inc.. It received FDA 510(k) clearance on 2026-05-28. The device is classified under product code OPR. It was reviewed by the NE advisory panel.
常見問題
What is the Intrasaccular Flow Disruption Device?
Intrasaccular Flow Disruption Device is a medical device that received FDA 510(k) clearance on 2026-05-28. The listed applicant is MicroVention, Inc..
When did Intrasaccular Flow Disruption Device receive FDA 510(k) clearance?
The clearance date for Intrasaccular Flow Disruption Device can be found in the official FDA records.
Who is the listed applicant for Intrasaccular Flow Disruption Device?
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 Intrasaccular Flow Disruption Device?
The FDA product code for Intrasaccular Flow Disruption Device is OPR.
相關臨床試驗
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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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