FDA 510(k)

Concerto Versa, 可拆式線圈

K 號：K202850 · 2021-02-09

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

決定日期2021-02-09

產品代碼KRD

諮詢委員會履歷

決定相當於

器材摘要

Concerto Versa, Detachable Coil 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 2021-02-09 under 510(k) number K202850. The device is classified under product code KRD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Concerto Versa, Detachable Coil?

Concerto Versa, Detachable Coil is a medical device that received FDA 510(k) clearance on 2021-02-09. The listed applicant is Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. The 510(k) number is K202850.

When did Concerto Versa, Detachable Coil receive FDA 510(k) clearance?

Concerto Versa, Detachable Coil received FDA 510(k) clearance on 2021-02-09, under 510(k) number K202850.

Who is the listed applicant for Concerto Versa, Detachable Coil?

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 Concerto Versa, Detachable Coil?

The FDA product code for Concerto Versa, Detachable Coil is KRD.