The following data is part of a De Novo classification by Vesiflo, Inc. with the FDA for Inflow Intraurethral Valve-pump.
| DeNovo ID | DEN130044 |
| Device Name: | INFLOW INTRAURETHRAL VALVE-PUMP |
| Classification | Urethral Insert With Pump For Bladder Drainage |
| Applicant | VESIFLO, INC. 8672 154th Ave Ne Redmond, WA 98052 |
| Contact | Kevin M Connolly |
| Product Code | PIH |
| CFR Regulation Number | 876.5140 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Gastroenterology/Urology |
| Classification Advisory | Gastroenterology/Urology |
| Type | Direct |
| Date Received | 2013-10-25 |
| Decision Date | 2014-10-14 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08625630003027 | DEN130044 | 000 |
| 00862563003085 | DEN130044 | 000 |
| 00862563003092 | DEN130044 | 000 |
| 00862563003108 | DEN130044 | 000 |
| 00862563003115 | DEN130044 | 000 |
| 00862563003122 | DEN130044 | 000 |
| 00862563003139 | DEN130044 | 000 |
| 00862563003146 | DEN130044 | 000 |
| 00862563003153 | DEN130044 | 000 |
| 00862563003160 | DEN130044 | 000 |
| 00862563003177 | DEN130044 | 000 |
| 00862563003184 | DEN130044 | 000 |
| 00862563003191 | DEN130044 | 000 |
| 08625630003003 | DEN130044 | 000 |
| 08625630003034 | DEN130044 | 000 |
| 08625630003001 | DEN130044 | 000 |
| 08625630003002 | DEN130044 | 000 |
| 08625630003010 | DEN130044 | 000 |
| 00862563003078 | DEN130044 | 000 |