21 CFR 870.1380 — Stylet, Catheter
Cardiovascular (CV) · Part 870 Subpart B—Cardiovascular Diagnostic Devices · § 870.1380
Identification
A catheter stylet is a wire that is run through a catheter or cannula to render it stiff.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DRB | Stylet, Catheter | 2 | 28 | 3rd Party |