The following data is part of a premarket notification filed by Hansen Medical, Inc. with the FDA for Hansen Medical Vascular Catheter Control System And Catheter.
| Device ID | K111004 |
| 510k Number | K111004 |
| Device Name: | HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETER |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-11 |
| Decision Date | 2012-05-29 |
| Summary: | summary |