FDA 510(k)

IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit

N.º K: K200807 · 2020-04-29

Fecha de decisión2020-04-29

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, Inc.. It received FDA 510(k) clearance on 2020-04-29 under 510(k) number K200807. 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 2020-04-29. The listed applicant is Irras USA, Inc.. The 510(k) number is K200807.

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 2020-04-29, under 510(k) number K200807.

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

The FDA 510(k) record lists Irras USA, Inc. 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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Otros registros que enlistan a Irras USA, Inc. como solicitante

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Fuente oficial

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