FDA Product Code NLG: Catheter, Intracardiac Mapping, High-density, Reprocessed
Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. (70 Fr 56911, Available At Https://www.govinfo.gov/content/pkg/fr-2005-09-29/pdf/05-19510.pdf).
Leading manufacturers include Innovative Health, LLC.
3
Total
3
Cleared
123d
Avg days
2019
Since
Stable submission activity - 0 submissions in the last 2 years
FDA 510(k) Cleared Catheter, Intracardiac Mapping, High-density, Reprocessed Devices (Product Code NLG)
3 devices
Cleared
Dec 20, 2021
Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled
Innovative Health, LLC
Cardiovascular
110d
Cleared
Nov 18, 2021
Reprocessed IntellaMap Orion High Resolution Mapping Catheter
Innovative Health, LLC
Cardiovascular
170d
About Product Code NLG - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code NLG since 2019, with 3 receiving FDA clearance (average review time: 123 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.
NLG devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →