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FDA 510(k)

EasyMap MAP Catheter

K-Number: K151139 · 2016-10-18

ApplicantMedfact Engineering GmbH
Decision Date2016-10-18
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

What is the EasyMap MAP Catheter?

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

When was EasyMap MAP Catheter approved by the FDA?

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

What company makes EasyMap MAP Catheter?

EasyMap MAP Catheter is manufactured by Medfact Engineering GmbH.

What is the FDA product code for EasyMap MAP Catheter?

The FDA product code for EasyMap MAP Catheter is DRF.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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