Product code
PZW: Catheter access cover, tamper-resistant
FDA product code · Class II · General Hospital
Key facts
| Product code | PZW |
|---|---|
| Device | Catheter access cover, tamper-resistant |
| Device class | Class II |
| Regulation number | 880.5970 |
| Review panel | General Hospital |
| Medical specialty | General Hospital |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | A tamper resistant catheter access cover is intended to control unauthorized access to a central venous catheter |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- None MAUDE adverse event reports
- None 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