HDE
H050001: WINGSPAN STENT SYSTEM WITH GATEWAY PTA BALLOON CATHETER
FDA Humanitarian Device Exemption · STRYKER CORP.
Key facts
| HDE number | H050001 |
|---|---|
| Trade name | WINGSPAN STENT SYSTEM WITH GATEWAY PTA BALLOON CATHETER |
| Generic name | Intracranial neurovascular stent |
| Applicant | STRYKER CORP. |
| Owner/operator | STRYKER CORP. |
| Product code | NJE |
| Approval date | Aug 3, 2005 |
| Docket number | 005M0308 |
| Establishment registration | 3008853977 |
| FEI number | 3008853977 |
At a glance
- 100–999 Supplements
- Apr 6, 2026 Latest supplement decision
- Yes Summary of safety and probable benefit on file
- 10–99 UDI device identifiers (GUDID)
- 1,000+ MAUDE adverse event reports
- 1–9 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: