The following data is part of a premarket notification filed by Hansen Medical with the FDA for Artisan Extend Control Catheter.
| Device ID | K122275 |
| 510k Number | K122275 |
| Device Name: | ARTISAN EXTEND CONTROL CATHETER |
| 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 | 2012-07-30 |
| Decision Date | 2012-08-29 |
| Summary: | summary |