FDA 510(k)

單一花束 X 再血管化設備

K 號：K203358 · 2021-03-01

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

決定日期2021-03-01

產品代碼POL

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

Solitaire X 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 2021-03-01 under 510(k) number K203358. 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 X Revascularization Device?

Solitaire X Revascularization Device is a medical device that received FDA 510(k) clearance on 2021-03-01. The listed applicant is Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. The 510(k) number is K203358.

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

Solitaire X Revascularization Device received FDA 510(k) clearance on 2021-03-01, under 510(k) number K203358.

Who is the listed applicant for Solitaire X 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 X Revascularization Device?

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