FDA 510(k)

BESPA Charcot System

Número K: K202326 · 2021-11-09

Data da decisão2021-11-09

Código do produtoHWC

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

BESPA Charcot System is the device name listed in this FDA 510(k) record. The listed applicant is Bespa Global, LLC. It received FDA 510(k) clearance on 2021-11-09 under 510(k) number K202326. 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 BESPA Charcot System?

BESPA Charcot System is a medical device that received FDA 510(k) clearance on 2021-11-09. The listed applicant is Bespa Global, LLC. The 510(k) number is K202326.

When did BESPA Charcot System receive FDA 510(k) clearance?

BESPA Charcot System received FDA 510(k) clearance on 2021-11-09, under 510(k) number K202326.

Who is the listed applicant for BESPA Charcot System?

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

What is the FDA product code for BESPA Charcot System?

The FDA product code for BESPA Charcot System is HWC. This falls under the Cardiovascular category.

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