INFLOW INTRAURETHRAL VALVE-PUMP
FDA 510(k) clearance DEN130044 · decided 2014-10-14
Clearance details
- K-number
- DEN130044
- Device name
- INFLOW INTRAURETHRAL VALVE-PUMP
- Applicant
- Vesiflo, Inc.
- Decision
- Unknown
- Date received
- 2013-10-25
- Decision date
- 2014-10-14
- Days to decision
- 354 days
- Clearance type
- Direct
- Product code
- PIH
- Device class
- 2
- Regulation number
- 876.5140
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Redmond, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.