The following data is part of a premarket notification filed by Hansen Medical with the FDA for Magellan Robotic System.
| Device ID | K141614 |
| 510k Number | K141614 |
| Device Name: | MAGELLAN ROBOTIC SYSTEM |
| Classification | System, Catheter Control, Steerable |
| Applicant | Hansen Medical 800 EAST MIDDLEFIELD ROAD Mountain View, CA 94043 |
| Contact | Kate W Lee |
| Correspondent | Kate W Lee Hansen Medical 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 | 2014-06-16 |
| Decision Date | 2014-08-07 |
| Summary: | summary |