The following data is part of a premarket notification filed by Hansen Medical with the FDA for Magellan Robotic Catheter 6fr (guide And Leader), Magellan Robotic Catheter 6fr Accessory Kit.
| Device ID | K133552 |
| 510k Number | K133552 |
| Device Name: | MAGELLAN ROBOTIC CATHETER 6FR (GUIDE AND LEADER), MAGELLAN ROBOTIC CATHETER 6FR ACCESSORY KIT |
| Classification | Catheter, Steerable |
| Applicant | Hansen Medical 800 EAST MIDDLEFIELD ROAD Mountain View, CA 94043 |
| Contact | Hassan Labay |
| Correspondent | Hassan Labay Hansen Medical 800 EAST MIDDLEFIELD ROAD Mountain View, CA 94043 |
| Product Code | DRA |
| CFR Regulation Number | 870.1280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-19 |
| Decision Date | 2014-02-07 |
| Summary: | summary |