21 CFR 870.1340 — Introducer, Catheter
Cardiovascular (CV) · Part 870 Subpart B—Cardiovascular Diagnostic Devices · § 870.1340
Identification
A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DYB | Introducer, Catheter | 2 | 700 | 3rd Party |
| OEX | Cardiovascular Catheter Sheath Introducer Kit | 2 | 0 | |
| OFC | Catheter Introducer Kit | 2 | 1 | |
| OFD | Catheter Introducer Kit | 2 | 0 | |
| OFJ | Lead Introducer Kit | 2 | 0 | |
| OFL | Percutaneous Sheath Introducer Kit | 2 | 0 | |
| PNE | Reprocessed Catheter Introducer | 2 | 7 |
