The following data is part of a premarket notification filed by Volcano Corporation with the FDA for Crux Vena Cava Filter System, Femoral; Crux Vena Cava Filter System, Jugular.
| Device ID | K150262 |
| 510k Number | K150262 |
| Device Name: | Crux Vena Cava Filter System, Femoral; Crux Vena Cava Filter System, Jugular |
| Classification | Filter, Intravascular, Cardiovascular |
| Applicant | Volcano Corporation 3721 Valley Centre Dr., Suite 500 San Diego, CA 92130 |
| Contact | Elaine Alan |
| Correspondent | Elaine Alan Volcano Corporation 3721 Valley Centre Dr., Suite 500 San Diego, CA 92130 |
| Product Code | DTK |
| CFR Regulation Number | 870.3375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-04 |
| Decision Date | 2015-04-03 |
| Summary: | summary |