HDE
H130001: KANEKA LIXELLE BETA 2-MICROGLOBULIN APHERESIS COLUMN
FDA Humanitarian Device Exemption · KANEKA PHARMA AMERICA LLC
Key facts
| HDE number | H130001 |
|---|---|
| Trade name | KANEKA LIXELLE BETA 2-MICROGLOBULIN APHERESIS COLUMN |
| Generic name | Beta 2-microglobulin apheresis column |
| Applicant | KANEKA PHARMA AMERICA LLC |
| Product code | PDI |
| Approval date | Mar 5, 2015 |
| Docket number | 15M-0909 |
| Notice date | Mar 19, 2015 |
At a glance
- 1–9 Supplements
- Apr 9, 2026 Latest supplement decision
- Yes Summary of safety and probable benefit on file
- 1–9 UDI device identifiers (GUDID)
- 10–99 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: