FDA 510(k)

OBSIDIO™ 可調適性栓塊 (M0013972101010)

K 號：K253376 · 2025-10-30

決定日期2025-10-30

產品代碼KRD

諮詢委員會履歷

決定相當於

器材摘要

OBSIDIO™ Conformable Embolic (M0013972101010) is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2025-10-30 under 510(k) number K253376. The device is classified under product code KRD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the OBSIDIO™ Conformable Embolic (M0013972101010)?

OBSIDIO™ Conformable Embolic (M0013972101010) is a medical device that received FDA 510(k) clearance on 2025-10-30. The listed applicant is Boston Scientific Corporation. The 510(k) number is K253376.

When did OBSIDIO™ Conformable Embolic (M0013972101010) receive FDA 510(k) clearance?

OBSIDIO™ Conformable Embolic (M0013972101010) received FDA 510(k) clearance on 2025-10-30, under 510(k) number K253376.

Who is the listed applicant for OBSIDIO™ Conformable Embolic (M0013972101010)?

FDA 510(k) 記錄中將波士頓科學公司列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for OBSIDIO™ Conformable Embolic (M0013972101010)?

The FDA product code for OBSIDIO™ Conformable Embolic (M0013972101010) is KRD.

其他以 Boston Scientific Corporation 為申請人之記錄

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。

K262151SpaceOAR Flex™ 系統 K261153LithoVue Elite數位柔軟輸尿管鏡系統 K261915導航™ Flex 腎管進入鞘組合 K262165FARADRIVE™操縱式鞘 (M004PF21M402)K262462TheraSphere 360™ Y-90 管理平台 K261488OBSIDIO 可調適性栓塊

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相關器械（代碼：KRD）

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。

K252812UniPearls® 遮斷微膠球Suzhou Haowei Medical Technology Co., Ltd.K261488OBSIDIO 可調適性栓塊Boston Scientific Corporation K261866Concerto Versa™ 可拆式線圈Medtronic, Inc.K260635HARBOR 閉塞設備Nuvascular, Inc.K260508LOBO血管栓塞系統Okami Medical, Inc.K253511Concerto Versa™ 可拆式線圈Medtronic, Inc.

官方來源

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