21 CFR 870.4875 — Stripper, Artery, Intraluminal
Cardiovascular (CV) · Part 870 Subpart E—Cardiovascular Surgical Devices · § 870.4875
Identification
An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DWX | Stripper, Artery, Intraluminal | 2 | 14 | 3rd Party |
| MCW | Catheter, Peripheral, Atherectomy | 2 | 146 | 3rd Party |
| QTF | Reprocessed Atherectomy Catheter | 2 | 1 |
