The following data is part of a premarket notification filed by Edwards Laboratories with the FDA for Vena Cava Umbrella Filter, Model 7321.
| Device ID | K771046 |
| 510k Number | K771046 |
| Device Name: | VENA CAVA UMBRELLA FILTER, MODEL 7321 |
| Classification | Filter, Intravascular, Cardiovascular |
| Applicant | EDWARDS LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DTK |
| CFR Regulation Number | 870.3375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-06-10 |
| Decision Date | 1977-06-22 |