Product code
PKP: Immunoglobulin g (igg) infusion system
FDA product code · Class II · General Hospital
Key facts
| Product code | PKP |
|---|---|
| Device | Immunoglobulin g (igg) infusion system |
| Device class | Class II |
| Regulation number | 880.5725 |
| 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 | An Immunoglobulin G (IgG) Infusion System is a prescription device intended for subcutaneous delivery of Immunoglobulin G (IgG) in accordance with the FDA approved labeling. |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 10–99 UDI devices (GUDID)
- 1–9 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