FDA 510(k)

EasyMap MAP Catheter

Número K: K151139 · 2016-10-18

Data da decisão2016-10-18

Código do produtoDRF

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

EasyMap MAP Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Medfact Engineering GmbH. It received FDA 510(k) clearance on 2016-10-18 under 510(k) number K151139. The device is classified under product code DRF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the EasyMap MAP Catheter?

EasyMap MAP Catheter is a medical device that received FDA 510(k) clearance on 2016-10-18. The listed applicant is Medfact Engineering GmbH. The 510(k) number is K151139.

When did EasyMap MAP Catheter receive FDA 510(k) clearance?

EasyMap MAP Catheter received FDA 510(k) clearance on 2016-10-18, under 510(k) number K151139.

Who is the listed applicant for EasyMap MAP Catheter?

The FDA 510(k) record lists Medfact Engineering GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EasyMap MAP Catheter?

The FDA product code for EasyMap MAP Catheter is DRF.

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