NKR · System, Catheter Control, Reprocessed
Cardiovascular · 21 CFR 870.1290 · Class 2
Overview
| Product Code | NKR |
|---|---|
| Device Name | System, Catheter Control, Reprocessed |
| Regulation | 21 CFR 870.1290 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
A steerable catheter control system is a device that is connected to the proximal end of a steerable guide wire that controls the motion of the steerable catheter.
Classification Rationale
Class II (performance standards).
Cleared Devices (0)
No cleared devices on record.
