FDA 510(k)

InCore MPJ System

Número K: K200124 · 2020-05-13

Data da decisão2020-05-13

Código do produtoHWC

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

InCore MPJ System is the device name listed in this FDA 510(k) record. The listed applicant is Nextremity Solutions, Inc.. It received FDA 510(k) clearance on 2020-05-13 under 510(k) number K200124. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the InCore MPJ System?

InCore MPJ System is a medical device that received FDA 510(k) clearance on 2020-05-13. The listed applicant is Nextremity Solutions, Inc.. The 510(k) number is K200124.

When did InCore MPJ System receive FDA 510(k) clearance?

InCore MPJ System received FDA 510(k) clearance on 2020-05-13, under 510(k) number K200124.

Who is the listed applicant for InCore MPJ System?

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

What is the FDA product code for InCore MPJ System?

The FDA product code for InCore MPJ System is HWC. This falls under the Cardiovascular category.

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Fonte oficial

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