510(k) DEN130044
DEN130044 is an FDA 510(k) premarket notification submitted by Vesiflo, Inc. for the device "INFLOW INTRAURETHRAL VALVE-PUMP". The FDA issued a decision of De Novo Granted on October 14, 2014. The device falls under product code PIH (Urethral Insert With Pump For Bladder Drainage), a Class II device regulated under 21 CFR 876.5140.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- October 14, 2014
- Date Received
- October 25, 2013
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Urethral Insert With Pump For Bladder Drainage
- Device Class
- Class II
- Regulation Number
- 876.5140
- Review Panel
- GU
- Submission Type
The device is intended to empty urine from the bladder under patient control.