The following data is part of a premarket notification filed by Hansen Medical, Inc. with the FDA for Sensei Catheter Control System.
| Device ID | K073225 |
| 510k Number | K073225 |
| Device Name: | SENSEI CATHETER CONTROL SYSTEM |
| Classification | System, Catheter Control, Steerable |
| Applicant | HANSEN MEDICAL, INC. 380 NORTH BERNARDO AVE. Mountain View, CA 94043 |
| Contact | Doug Worth |
| Correspondent | Doug Worth HANSEN MEDICAL, INC. 380 NORTH BERNARDO AVE. Mountain View, CA 94043 |
| Product Code | DXX |
| CFR Regulation Number | 870.1290 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-15 |
| Decision Date | 2008-06-30 |
| Summary: | summary |