Magellan Robotic System, Magellan Robotic Catheter 10Fr
Device Facts
| Record ID | K143227 |
|---|---|
| Device Name | Magellan Robotic System, Magellan Robotic Catheter 10Fr |
| Applicant | Hansen Medical, Inc. |
| Product Code | DXX · Cardiovascular |
| Decision Date | Jul 1, 2015 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1290 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A steerable catheter control system is a device that is connected to the proximal end of a steerable guide wire that controls the motion of the steerable catheter.
