QTF · Reprocessed Atherectomy Catheter
Cardiovascular · 21 CFR 870.4875 · Class 2
Overview
| Product Code | QTF |
|---|---|
| Device Name | Reprocessed Atherectomy Catheter |
| Regulation | 21 CFR 870.4875 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
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).
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K220171 | NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter | Northeast Scientific, Inc. | Jul 1, 2022 | SESE |
Top Applicants
- Northeast Scientific, Inc. — 1 clearance
