FDA 510(k)

InZone IST 分離系統；IZDS 連接線

K 號：K251832 · 2025-10-17

決定日期2025-10-17

產品代碼HCG

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

InZone IST Detachment System; IZDS Connecting Cable is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Neurovascular. It received FDA 510(k) clearance on 2025-10-17 under 510(k) number K251832. The device is classified under product code HCG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the InZone IST Detachment System; IZDS Connecting Cable?

InZone IST Detachment System; IZDS Connecting Cable is a medical device that received FDA 510(k) clearance on 2025-10-17. The listed applicant is Stryker Neurovascular. The 510(k) number is K251832.

When did InZone IST Detachment System; IZDS Connecting Cable receive FDA 510(k) clearance?

InZone IST Detachment System; IZDS Connecting Cable received FDA 510(k) clearance on 2025-10-17, under 510(k) number K251832.

Who is the listed applicant for InZone IST Detachment System; IZDS Connecting Cable?

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

What is the FDA product code for InZone IST Detachment System; IZDS Connecting Cable?

The FDA product code for InZone IST Detachment System; IZDS Connecting Cable is HCG.

其他以 Stryker Neurovascular 為申請人之記錄

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K261889Trevo Trak 21 微导管 K253032AXS Lift 颅内基底導管 K252694目標可拆式線圈 K242289Excelsior XT-27 微导管，Excelsior XT-27 強化微导管，Excelsior XT-27 預成型微导管，Excelsior XT-27 強化預成型微导管 K243593AXS Lift 颅内基底導管 K241637回聲內顱底針心管

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相關器械（代碼：HCG）

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

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