FDA 510(k)

Axium Detachable Coil; Axium Prime Detachable Coil

Número K: K203432 · 2021-07-07

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

Data da decisão2021-07-07

Código do produtoHCG

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Axium Detachable Coil; Axium Prime 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 2021-07-07 under 510(k) number K203432. The device is classified under product code HCG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Axium Detachable Coil; Axium Prime Detachable Coil?

Axium Detachable Coil; Axium Prime Detachable Coil is a medical device that received FDA 510(k) clearance on 2021-07-07. The listed applicant is Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. The 510(k) number is K203432.

When did Axium Detachable Coil; Axium Prime Detachable Coil receive FDA 510(k) clearance?

Axium Detachable Coil; Axium Prime Detachable Coil received FDA 510(k) clearance on 2021-07-07, under 510(k) number K203432.

Who is the listed applicant for Axium Detachable Coil; Axium Prime 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 Axium Detachable Coil; Axium Prime Detachable Coil?

The FDA product code for Axium Detachable Coil; Axium Prime Detachable Coil is HCG.

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Fonte oficial

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