FDA 510(k)

Axium 可拆卸线圈；Axium Prime 可拆卸线圈

K 號：K233420 · 2023-11-07

申請人Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular

決定日期2023-11-07

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

Axium Detachable Coil; Axium Prime Detachable Coil is the device name listed in this FDA 510(k) record. The listed applicant is Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular. It received FDA 510(k) clearance on 2023-11-07 under 510(k) number K233420. 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 Axium Detachable Coil; Axium Prime Detachable Coil?

Axium Detachable Coil; Axium Prime Detachable Coil is a medical device that received FDA 510(k) clearance on 2023-11-07. The listed applicant is Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular. The 510(k) number is K233420.

When did Axium Detachable Coil; Axium Prime Detachable Coil receive FDA 510(k) clearance?

Axium Detachable Coil; Axium Prime Detachable Coil received FDA 510(k) clearance on 2023-11-07, under 510(k) number K233420.

Who is the listed applicant for Axium Detachable Coil; Axium Prime Detachable Coil?

The FDA 510(k) record lists Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Axium Detachable Coil; Axium Prime Detachable Coil?

The FDA product code for Axium Detachable Coil; Axium Prime Detachable Coil is HCG.

其他以 Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular 為申請人之記錄

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相關器械（代碼：HCG）

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官方來源

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