FDA 510(k)

目標可拆式線圈

K 號：K252694 · 2025-12-11

決定日期2025-12-11

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

Target Detachable Coil is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Neurovascular. It received FDA 510(k) clearance on 2025-12-11 under 510(k) number K252694. 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 Target Detachable Coil?

Target Detachable Coil is a medical device that received FDA 510(k) clearance on 2025-12-11. The listed applicant is Stryker Neurovascular. The 510(k) number is K252694.

When did Target Detachable Coil receive FDA 510(k) clearance?

Target Detachable Coil received FDA 510(k) clearance on 2025-12-11, under 510(k) number K252694.

Who is the listed applicant for Target Detachable Coil?

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 Target Detachable Coil?

The FDA product code for Target Detachable Coil 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 K251832InZone IST 分離系統；IZDS 連接線 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）

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官方來源

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