NLG · Class II · 21 CFR 870.1220

Catheter, Intracardiac Mapping, High-density, Reprocessed — FDA 510(k) Devices

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).

2
Total
2
Cleared
140d
Avg days
2021
Since

List of Catheter, Intracardiac Mapping, High-density, Reprocessed devices cleared through 510(k)

2 devices
1–2 of 2
Cleared Dec 20, 2021
Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled
K212776
Innovative Health, LLC
Cardiovascular · 110d
Cleared Nov 18, 2021
Reprocessed IntellaMap Orion High Resolution Mapping Catheter
K211662
Innovative Health, LLC
Cardiovascular · 170d

How to use this database

This page lists all FDA 510(k) submissions for Catheter, Intracardiac Mapping, High-density, Reprocessed devices (product code NLG). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Cardiovascular FDA review panel. Browse all Cardiovascular devices →