FDA 510(k)

Firefly Peritoneal Dialysis Connector Disinfection System

N.º K: K151620 · 2016-01-20

Fecha de decisión2016-01-20

Código de productoKDJ

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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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Otros registros que enlistan a Puracath Medical, Inc. como solicitante

K251375PuraCath Firefly Needleless Connector IT (9005)K203796Firefly Needleless Connector

Dispositivos relacionados (Código: KDJ)

Fuente oficial

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