The following data is part of a premarket notification filed by B Braun with the FDA for Vena Tech Vena Cava Filter; Vena Tech 30d Vena Cava Filter; Vena Tech Lp Cave Filter.
| Device ID | K010485 |
| 510k Number | K010485 |
| Device Name: | VENA TECH VENA CAVA FILTER; VENA TECH 30D VENA CAVA FILTER; VENA TECH LP CAVE FILTER |
| Classification | Filter, Intravascular, Cardiovascular |
| Applicant | B BRAUN 2934 CENTRAL STREET, SUITE 1A Evanston, IL 60201 |
| Contact | Paul O'connell |
| Correspondent | Paul O'connell B BRAUN 2934 CENTRAL STREET, SUITE 1A 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 | 2001-02-20 |
| Decision Date | 2001-05-18 |