The following data is part of a premarket notification filed by Vena-tech, Inc. with the FDA for Vena Cava Filter.
| Device ID | K881604 |
| 510k Number | K881604 |
| Device Name: | VENA CAVA FILTER |
| Classification | Filter, Intravascular, Cardiovascular |
| Applicant | VENA-TECH, INC. 1152 BEACON ST. Brookline, MA 02164 |
| Contact | Allan R Frrelon |
| Correspondent | Allan R Frrelon VENA-TECH, INC. 1152 BEACON ST. Brookline, MA 02164 |
| Product Code | DTK |
| CFR Regulation Number | 870.3375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-12 |
| Decision Date | 1989-03-10 |