The following data is part of a premarket notification filed by Hansen Medical, Inc. with the FDA for Hansen Medical Magellan Robotic Catheter Ekit.
| Device ID | K153304 |
| 510k Number | K153304 |
| Device Name: | Hansen Medical Magellan Robotic Catheter EKit |
| Classification | Catheter, Steerable |
| Applicant | Hansen Medical, Inc. 800 E Middlefield Road Mountain View, CA 94043 |
| Contact | Marysa Loustalot |
| Correspondent | Marysa Loustalot Hansen Medical, Inc. 800 E Middlefield Road Mountain View, CA 94043 |
| Product Code | DRA |
| CFR Regulation Number | 870.1280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-16 |
| Decision Date | 2016-02-01 |
| Summary: | summary |