HDE
H210004: NeVa VS
FDA Humanitarian Device Exemption · Vesalio
Key facts
| HDE number | H210004 |
|---|---|
| Trade name | NeVa VS |
| Generic name | Temporary percutaneous transluminal cerebral artery dilatation device |
| Applicant | Vesalio |
| Owner/operator | Vesalio, Inc |
| Product code | QTK |
| Approval date | Sep 9, 2022 |
| Docket number | 22M-2197 |
| Notice date | Sep 12, 2022 |
| Establishment registration | 3014498720 |
| FEI number | 3014498720 |
At a glance
- 1–9 Supplements
- Mar 11, 2025 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: