FDA 510(k)

Axium 可拆卸线圈；Axium Prime 可拆卸线圈

K号: K233420 · 2023-11-07

申请人Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular

决定日期2023-11-07

产品代码HCG

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决定实质等同

器械摘要

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.

常见问题

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.

列明Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K241177React 71 导管 K210230Phenom 导管

相关器械（代码：HCG）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

官方来源

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