The following data is part of a premarket notification filed by Rmt Medical Technilogies Inc. with the FDA for Safeflo Vena Cava Filter.
| Device ID | K081138 |
| 510k Number | K081138 |
| Device Name: | SAFEFLO VENA CAVA FILTER |
| Classification | Filter, Intravascular, Cardiovascular |
| Applicant | RMT MEDICAL TECHNILOGIES INC. 1835 MARKET STREET SUITE 200 Philadelphia, PA 19103 |
| Contact | Janice M Hogan |
| Correspondent | Janice M Hogan RMT MEDICAL TECHNILOGIES INC. 1835 MARKET STREET SUITE 200 Philadelphia, PA 19103 |
| Product Code | DTK |
| CFR Regulation Number | 870.3375 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-21 |
| Decision Date | 2009-05-07 |
| Summary: | summary |