The following data is part of a premarket notification filed by Hansen Medical, Inc. with the FDA for Magellan Robotic System, Magellan Robotic Catheter 10fr.
| Device ID | K143227 |
| 510k Number | K143227 |
| Device Name: | Magellan Robotic System, Magellan Robotic Catheter 10Fr |
| Classification | System, Catheter Control, Steerable |
| Applicant | HANSEN MEDICAL, INC. 800 E. MIDDLEFIELD ROAD Mountain View, CA 94043 |
| Contact | Todd Milholland |
| Correspondent | Todd Milholland HANSEN MEDICAL, INC. 800 E. 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 | 2014-11-10 |
| Decision Date | 2015-07-01 |