FDA 510(k)

Solitaire 2 Revascularization Device

K号: K162539 · 2016-11-10

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

决定日期2016-11-10

产品代码POL

咨询委员会NE

决定Substantially Equivalent

器械摘要

Solitaire 2 Revascularization Device 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 2016-11-10 under 510(k) number K162539. The device is classified under product code POL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Solitaire 2 Revascularization Device?

Solitaire 2 Revascularization Device is a medical device that received FDA 510(k) clearance on 2016-11-10. The listed applicant is Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. The 510(k) number is K162539.

When did Solitaire 2 Revascularization Device receive FDA 510(k) clearance?

Solitaire 2 Revascularization Device received FDA 510(k) clearance on 2016-11-10, under 510(k) number K162539.

Who is the listed applicant for Solitaire 2 Revascularization Device?

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 Solitaire 2 Revascularization Device?

The FDA product code for Solitaire 2 Revascularization Device is POL.

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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