The following data is part of a premarket notification filed by Crux Biomedical with the FDA for Crux Vena Cava Filter System.
| Device ID | K122585 |
| 510k Number | K122585 |
| Device Name: | CRUX VENA CAVA FILTER SYSTEM |
| Classification | Filter, Intravascular, Cardiovascular |
| Applicant | CRUX BIOMEDICAL 1455 ADAMS DRIVE, #1170 Menlo Park, CA 94025 |
| Contact | Elisa Hebb |
| Correspondent | Elisa Hebb CRUX BIOMEDICAL 1455 ADAMS DRIVE, #1170 Menlo Park, CA 94025 |
| Product Code | DTK |
| CFR Regulation Number | 870.3375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-24 |
| Decision Date | 2013-01-17 |
| Summary: | summary |