FDA 510(k)

Solitaire 2 Revascularization Device

K 號：K162539 · 2016-11-10

申請人Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

決定日期2016-11-10

產品代碼POL

諮詢委員會NE

決定Substantially Equivalent

器材摘要

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.

常見問題

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.