NKS · Catheter, Steerable, Reprocessed
Cardiovascular · 21 CFR 870.1280 · Class 2
Overview
| Product Code | NKS |
|---|---|
| Device Name | Catheter, Steerable, Reprocessed |
| Regulation | 21 CFR 870.1280 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (0 of 0)
No cleared devices on record.