21 CFR 870.1310 — Dilator, Vessel, For Percutaneous Catheterization
Cardiovascular (CV) · Part 870 Subpart B—Cardiovascular Diagnostic Devices · § 870.1310
Identification
A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 2 | 104 | 3rd Party |
