21 CFR 870.1280 — Catheter, Steerable
Cardiovascular (CV) · Part 870 Subpart B—Cardiovascular Diagnostic Devices · § 870.1280
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).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DRA | Catheter, Steerable | 2 | 41 | 3rd Party |
| NKS | Catheter, Steerable, Reprocessed | 2 | 0 | 3rd Party |
