FDA 510(k)

CRF Radiofrequency Ablation System

N.º K: K192715 · 2020-01-07

SolicitanteCambridge Interventional, LLC

Fecha de decisión2020-01-07

Código de productoGEI

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

CRF Radiofrequency Ablation System is the device name listed in this FDA 510(k) record. The listed applicant is Cambridge Interventional, LLC. It received FDA 510(k) clearance on 2020-01-07 under 510(k) number K192715. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the CRF Radiofrequency Ablation System?

CRF Radiofrequency Ablation System is a medical device that received FDA 510(k) clearance on 2020-01-07. The listed applicant is Cambridge Interventional, LLC. The 510(k) number is K192715.

When did CRF Radiofrequency Ablation System receive FDA 510(k) clearance?

CRF Radiofrequency Ablation System received FDA 510(k) clearance on 2020-01-07, under 510(k) number K192715.

Who is the listed applicant for CRF Radiofrequency Ablation System?

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

What is the FDA product code for CRF Radiofrequency Ablation System?

The FDA product code for CRF Radiofrequency Ablation System is GEI.

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