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FDA 510(k)

IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit

N.º K: K192289 · 2019-11-15

SolicitanteIrras USA, Ltd.
Fecha de decisión2019-11-15
Código de productoJXG
Comité asesorNE
DecisiónSubstantially Equivalent

Resumen del dispositivo

IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit is the device name listed in this FDA 510(k) record. The listed applicant is Irras USA, Ltd.. It received FDA 510(k) clearance on 2019-11-15 under 510(k) number K192289. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit?

IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit is a medical device that received FDA 510(k) clearance on 2019-11-15. The listed applicant is Irras USA, Ltd.. The 510(k) number is K192289.

When did IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit receive FDA 510(k) clearance?

IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit received FDA 510(k) clearance on 2019-11-15, under 510(k) number K192289.

Who is the listed applicant for IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit?

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

What is the FDA product code for IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit?

The FDA product code for IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit is JXG.

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Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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