HDE
H240004: PHIL Liquid Embolic System
FDA Humanitarian Device Exemption · MicroVention, Inc.
Key facts
| HDE number | H240004 |
|---|---|
| Trade name | PHIL Liquid Embolic System |
| Generic name | Dural arteriovenous fistula liquid embolic |
| Applicant | MicroVention, Inc. |
| Owner/operator | MicroVention Inc. |
| Product code | SGF |
| Approval date | Dec 31, 2025 |
| Docket number | FDA-0463 |
| Notice date | Nov 16, 2026 |
| Establishment registration | 3013556777 |
| FEI number | 3013556777 |
At a glance
- 1–9 Supplements
- May 28, 2026 Latest supplement decision
- Yes Summary of safety and probable benefit on file
- 1–9 UDI device identifiers (GUDID)
- None 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: