HDE
H120005: LIPOSORBER LA-15 SYSTEM
FDA Humanitarian Device Exemption · KANEKA PHARMA AMERICA LLC
Key facts
| HDE number | H120005 |
|---|---|
| Trade name | LIPOSORBER LA-15 SYSTEM |
| Generic name | Apheresis for focal glomerulosclerosis in adult and pediatric patients |
| Applicant | KANEKA PHARMA AMERICA LLC |
| Owner/operator | KANEKA CORP. |
| Product code | PBN |
| Approval date | Oct 10, 2013 |
| Docket number | 13M-1322 |
| Notice date | Oct 30, 2013 |
| Establishment registration | 3031408734 |
| FEI number | 3031408734 |
At a glance
- 10–99 Supplements
- Aug 26, 2026 Latest supplement decision
- Yes Summary of safety and probable benefit on file
- 1–9 UDI device identifiers (GUDID)
- 1–9 MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About HDE approvals
A Humanitarian Device Exemption (HDE) authorizes devices intended to benefit patients with rare diseases or conditions affecting small populations in the United States.
Source: U.S. Food and Drug Administration (FDA), Humanitarian Device Exemption (HDE) database · Source date: