HDE
H960001: HARRISON FETAL BLADDER STENT SET
FDA Humanitarian Device Exemption · Cook Incorporated
Key facts
| HDE number | H960001 |
|---|---|
| Trade name | HARRISON FETAL BLADDER STENT SET |
| Generic name | Stent, bladder, fetal |
| Applicant | Cook Incorporated |
| Owner/operator | COOK, INC. |
| Product code | MPR |
| Approval date | Feb 14, 1997 |
| Docket number | 97M-0124 |
| Notice date | Apr 7, 1997 |
| Establishment registration | 1820334 |
| FEI number | 1820334 |
At a glance
- 1–9 Supplements
- Feb 22, 2013 Latest supplement decision
- No 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: