Product code
QTF: Reprocessed atherectomy catheter
FDA product code · Class II · Cardiovascular
Key facts
| Product code | QTF |
|---|---|
| Device | Reprocessed atherectomy catheter |
| Device class | Class II |
| Regulation number | 870.4875 |
| Review panel | Cardiovascular |
| Medical specialty | Cardiovascular |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Reprocessed atherectomy device for peripheral vasculature. Reprocessing validation data for this device type must be included in a 510(k) submission |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 10–99 UDI devices (GUDID)
- None MAUDE adverse event reports
- 1–9 Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database