FDA 510(k)

Solitaire Platinum Revascularization Device

Número K: K161879 · 2016-09-21

RequerenteMicro Therapeutics, Inc. d/b/a ev3 Neurovascular

Data da decisão2016-09-21

Código do produtoNRY

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Solitaire Platinum 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 2016-09-21 under 510(k) number K161879. The device is classified under product code NRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Solitaire Platinum Revascularization Device?

Solitaire Platinum Revascularization Device is a medical device that received FDA 510(k) clearance on 2016-09-21. The listed applicant is Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. The 510(k) number is K161879.

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

Solitaire Platinum Revascularization Device received FDA 510(k) clearance on 2016-09-21, under 510(k) number K161879.

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

The FDA product code for Solitaire Platinum Revascularization Device is NRY.

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Fonte oficial

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