FDA product code NLG: Catheter, Intracardiac Mapping, High-Density, Reprocessed
NLG is the FDA product code for catheter, intracardiac mapping, high-density, reprocessed. It is a Class II device, regulated under 21 CFR 870.1220 and reviewed by the Cardiovascular panel. FDA has cleared 3 510(k) submissions under NLG. The average 510(k) review took 123 days (median 110).
Definition
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).
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Intracardiac Mapping, High-Density, Reprocessed |
| Device class | Class II |
| Regulation | 21 CFR 870.1220 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for NLG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 90 |
| 2021 | 2 | 140 |
Compare with all 510(k) review times · Search every NLG clearance
Top NLG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Innovative Health, LLC | 3 | 2021-12-20 |
Most recent NLG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K212776 | Innovative Health, LLC | Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled | 2021-12-20 | 110 |
| K211662 | Innovative Health, LLC | Reprocessed IntellaMap Orion High Resolution Mapping Catheter | 2021-11-18 | 170 |
| K190785 | Innovative Health, LLC | Reprocessed PentaRay Nav eco High-Density Mapping Catheter | 2019-06-25 | 90 |
Recalls for NLG devices
openFDA lists no recalls for product code NLG.
Frequently asked questions
What is FDA product code NLG?
NLG is the FDA product code for catheter, intracardiac mapping, high-density, reprocessed. It is a Class II device, regulated under 21 CFR 870.1220 and reviewed by the Cardiovascular panel.
What device class is NLG?
Class II, regulation 21 CFR 870.1220. Typical premarket route: 510(k).
How long does a 510(k) take for product code NLG?
Across 3 cleared submissions the average was 123 days from receipt to decision (median 110).
Which companies have the most NLG clearances?
Innovative Health, LLC (3).
Next steps
- Run an FDA pathway report with predicate devices for product code NLG
- Run a recall and safety report across every NLG manufacturer
- Watch product code NLG for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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