The following data is part of a premarket notification filed by Hansen Medical, Inc. with the FDA for Sensei X Robotic Catheter System.
| Device ID | K102168 |
| 510k Number | K102168 |
| Device Name: | SENSEI X ROBOTIC CATHETER SYSTEM |
| Classification | System, Catheter Control, Steerable |
| Applicant | HANSEN MEDICAL, INC. 800 EAST MIDDLEFIELD ROAD Mountain View, CA 94043 |
| Contact | Kate Whitin |
| Correspondent | Kate Whitin HANSEN MEDICAL, INC. 800 EAST MIDDLEFIELD ROAD Mountain View, CA 94043 |
| Product Code | DXX |
| CFR Regulation Number | 870.1290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-02 |
| Decision Date | 2010-10-22 |
| Summary: | summary |