FDA 510(k)

Firefly Peritoneal Dialysis Connector Disinfection System

Número K: K151620 · 2016-01-20

Data da decisão2016-01-20

Código do produtoKDJ

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Firefly Peritoneal Dialysis Connector Disinfection System is the device name listed in this FDA 510(k) record. The listed applicant is Puracath Medical, Inc.. It received FDA 510(k) clearance on 2016-01-20 under 510(k) number K151620. The device is classified under product code KDJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Firefly Peritoneal Dialysis Connector Disinfection System?

Firefly Peritoneal Dialysis Connector Disinfection System is a medical device that received FDA 510(k) clearance on 2016-01-20. The listed applicant is Puracath Medical, Inc.. The 510(k) number is K151620.

When did Firefly Peritoneal Dialysis Connector Disinfection System receive FDA 510(k) clearance?

Firefly Peritoneal Dialysis Connector Disinfection System received FDA 510(k) clearance on 2016-01-20, under 510(k) number K151620.

Who is the listed applicant for Firefly Peritoneal Dialysis Connector Disinfection System?

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

What is the FDA product code for Firefly Peritoneal Dialysis Connector Disinfection System?

The FDA product code for Firefly Peritoneal Dialysis Connector Disinfection System is KDJ.

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Dispositivos Relacionados (Código: KDJ)

Fonte oficial

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