The following data is part of a premarket notification filed by Vena-tech, Inc. with the FDA for Vena Cava Filter.
| Device ID | K901454 |
| 510k Number | K901454 |
| Device Name: | VENA CAVA FILTER |
| Classification | Filter, Intravascular, Cardiovascular |
| Applicant | VENA-TECH, INC. 1801 MAPLE Evanston, IL 60201 |
| Contact | Paul O'connell |
| Correspondent | Paul O'connell VENA-TECH, INC. 1801 MAPLE Evanston, IL 60201 |
| Product Code | DTK |
| CFR Regulation Number | 870.3375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-27 |
| Decision Date | 1991-05-29 |