PIH
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Urethral Insert With Pump For Bladder Drainage
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5140
- Medical specialty
- Gastroenterology, Urology
- Flags
- Implant
- FDA definition
- The device is intended to empty urine from the bladder under patient control.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| INFLOW INTRAURETHRAL VALVE-PUMP (DEN130044) | Vesiflo, Inc. | 2014-10-14 |
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