FDA Product Code
FDA Product Code NLG — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1220
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K212776 | Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled | Innovative Health, LLC | 2021-12-20 | Traditional | PDF ↗ |
| K211662 | Reprocessed IntellaMap Orion High Resolution Mapping Catheter | Innovative Health, LLC | 2021-11-18 | Traditional | PDF ↗ |
| K190785 | Reprocessed PentaRay Nav eco High-Density Mapping Catheter | Innovative Health, LLC | 2019-06-25 | Traditional | PDF ↗ |
Product code NLG · Class II · Cardiovascular. Data: openFDA.