NLG — Catheter, Intracardiac Mapping, High-Density, Reprocessed Class II
Classification Details
- Product Code
- NLG
- Device Class
- Class II
- Regulation Number
- 870.1220
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
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).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K212776 | innovative health | Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled | December 20, 2021 |
| K211662 | innovative health | Reprocessed IntellaMap Orion High Resolution Mapping Catheter | November 18, 2021 |
| K190785 | innovative health | Reprocessed PentaRay Nav eco High-Density Mapping Catheter | June 25, 2019 |