HDE
H970001: KCH FETAL BLADDER DRAINAGE CATHETER
FDA Humanitarian Device Exemption · ROCKET MEDICAL PLC
Key facts
| HDE number | H970001 |
|---|---|
| Trade name | KCH FETAL BLADDER DRAINAGE CATHETER |
| Generic name | Stent, bladder, fetal |
| Applicant | ROCKET MEDICAL PLC |
| Owner/operator | Rocket Medical Plc |
| Product code | MPR |
| Approval date | Sep 30, 1997 |
| Docket number | 98M-0164 |
| Establishment registration | 9610632 |
| FEI number | 3002808026 |
At a glance
- 1–9 Supplements
- Oct 16, 2019 Latest supplement decision
- No Summary of safety and probable benefit on file
- 10–99 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: