NLG · Catheter, Intracardiac Mapping, High-Density, Reprocessed
Cardiovascular · 21 CFR 870.1220 · Class 2
Overview
| Product Code | NLG |
|---|---|
| Device Name | Catheter, Intracardiac Mapping, High-Density, Reprocessed |
| Regulation | 21 CFR 870.1220 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
Identification
An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K212776 | Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled | Innovative Health, LLC | Dec 20, 2021 | SESE |
| K211662 | Reprocessed IntellaMap Orion High Resolution Mapping Catheter | Innovative Health, LLC | Nov 18, 2021 | SESE |
| K190785 | Reprocessed PentaRay Nav eco High-Density Mapping Catheter | Innovative Health, LLC | Jun 25, 2019 | SESE |
Top Applicants
- Innovative Health, LLC — 3 clearances
