FDA 510(k) Applications for Medical Device Product Code "NLG"
(Catheter, Mapping, Intracardiac, Reprocessed)

FDA 510(k) Number Applicant Device Name Decision Date
K212776 Innovative Health, LLC. Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled 12/20/2021
K211662 Innovative Health, LLC. Reprocessed IntellaMap Orion High Resolution Mapping Catheter 11/18/2021
K190785 Innovative Health, LLC. Reprocessed PentaRay Nav eco High-Density Mapping Catheter 06/25/2019


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