FDA 510(k)

Penumbra LP Coil System

Número K: K230284 · 2023-10-25

Data da decisão2023-10-25

Código do produtoHCG

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Penumbra LP Coil System is the device name listed in this FDA 510(k) record. The listed applicant is Penumbra, Inc.. It received FDA 510(k) clearance on 2023-10-25 under 510(k) number K230284. 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 Penumbra LP Coil System?

Penumbra LP Coil System is a medical device that received FDA 510(k) clearance on 2023-10-25. The listed applicant is Penumbra, Inc.. The 510(k) number is K230284.

When did Penumbra LP Coil System receive FDA 510(k) clearance?

Penumbra LP Coil System received FDA 510(k) clearance on 2023-10-25, under 510(k) number K230284.

Who is the listed applicant for Penumbra LP Coil System?

The FDA 510(k) record lists Penumbra, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Penumbra LP Coil System?

The FDA product code for Penumbra LP Coil System is HCG.

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