HDE
H030005: COAXIA NEUROFLO CATHETER
FDA Humanitarian Device Exemption · ZOLL CIRCULATION
Key facts
| HDE number | H030005 |
|---|---|
| Trade name | COAXIA NEUROFLO CATHETER |
| Generic name | Catheter, neuro-vasculature, occluding balloon |
| Applicant | ZOLL CIRCULATION |
| Owner/operator | ZOLL Medical Corporation |
| Product code | PAV |
| Approval date | Mar 30, 2005 |
| Docket number | 05M-0132 |
| Establishment registration | 3010617000 |
| FEI number | 3003793491 |
At a glance
- 1–9 Supplements
- Oct 3, 2014 Latest supplement decision
- Yes Summary of safety and probable benefit on file
- 1–9 UDI device identifiers (GUDID)
- None 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: