21 CFR 870.1220 — Catheter, Electrode Recording, Or Probe, Electrode Recording
Cardiovascular (CV) · Part 870 Subpart B—Cardiovascular Diagnostic Devices · § 870.1220
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).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 2 | 186 | |
| MTD | Catheter, Intracardiac Mapping, High-Density Array | 2 | 34 | |
| NLG | Catheter, Intracardiac Mapping, High-Density, Reprocessed | 2 | 3 | |
| NLH | Catheter, Recording, Electrode, Reprocessed | 2 | 70 |
