The following data is part of a premarket notification filed by Rex Medical with the FDA for Option Vena Cava Filter.
| Device ID | K081410 |
| 510k Number | K081410 |
| Device Name: | OPTION VENA CAVA FILTER |
| Classification | Filter, Intravascular, Cardiovascular |
| Applicant | REX MEDICAL 386 W. MAIN STREET SUITE 7 Northborough, MA 01532 |
| Contact | Leo Basta |
| Correspondent | Leo Basta REX MEDICAL 386 W. MAIN STREET SUITE 7 Northborough, MA 01532 |
| Product Code | DTK |
| CFR Regulation Number | 870.3375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-20 |
| Decision Date | 2009-06-04 |
| Summary: | summary |