510(k) DEN130044
- Device
- INFLOW INTRAURETHRAL VALVE-PUMP
- Applicant
- Vesiflo, Inc.
- 510(k) number
- DEN130044
- Product code
- PIH
- Decision
- Unknown (DENG)
- Decision date
- 2014-10-14
- Date received
- 2013-10-25
- Regulation
- 876.5140
- Classification name
- Urethral Insert With Pump For Bladder Drainage
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- KEVIN M CONNOLLY
- Address
- 8672 154th Ave. NE Redmond WA US 98052 98052
FDA Registration Numbers#
- 1222928
Source Documents#
510(k) summary PDF not indicated by FDA