FDA 510(k)

Rebar Micro Catheter

Número K: K210114 · 2021-02-16

RequerenteMicro Therapeuatics, Inc. D/B/A Ev3 Neurovascular

Data da decisão2021-02-16

Código do produtoKRA

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Rebar Micro Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Micro Therapeuatics, Inc. D/B/A Ev3 Neurovascular. It received FDA 510(k) clearance on 2021-02-16 under 510(k) number K210114. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Rebar Micro Catheter?

Rebar Micro Catheter is a medical device that received FDA 510(k) clearance on 2021-02-16. The listed applicant is Micro Therapeuatics, Inc. D/B/A Ev3 Neurovascular. The 510(k) number is K210114.

When did Rebar Micro Catheter receive FDA 510(k) clearance?

Rebar Micro Catheter received FDA 510(k) clearance on 2021-02-16, under 510(k) number K210114.

Who is the listed applicant for Rebar Micro Catheter?

The FDA 510(k) record lists Micro Therapeuatics, 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 Rebar Micro Catheter?

The FDA product code for Rebar Micro Catheter is KRA.

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Fonte oficial

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