FDA 510(k)

Navien Intracranial Support Catheter

K号: K161152 · 2016-10-12

申请人Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

决定日期2016-10-12

产品代码DQY

咨询委员会CV

决定Substantially Equivalent

器械摘要

Navien Intracranial Support Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. It received FDA 510(k) clearance on 2016-10-12 under 510(k) number K161152. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Navien Intracranial Support Catheter?

Navien Intracranial Support Catheter is a medical device that received FDA 510(k) clearance on 2016-10-12. The listed applicant is Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. The 510(k) number is K161152.

When did Navien Intracranial Support Catheter receive FDA 510(k) clearance?

Navien Intracranial Support Catheter received FDA 510(k) clearance on 2016-10-12, under 510(k) number K161152.

Who is the listed applicant for Navien Intracranial Support Catheter?

The FDA 510(k) record lists Micro Therapeutics, Inc. d/b/a ev3 Neurovascular as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Navien Intracranial Support Catheter?

The FDA product code for Navien Intracranial Support Catheter is DQY.

列明Micro Therapeutics, Inc. 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。

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