The following data is part of a premarket notification filed by Hansen Medical, Inc. with the FDA for Hansen Medical Dilator For Artisan Control Catheter.
| Device ID | K082075 |
| 510k Number | K082075 |
| Device Name: | HANSEN MEDICAL DILATOR FOR ARTISAN CONTROL CATHETER |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | HANSEN MEDICAL, INC. 800 E. MIDDLEFIELD ROAD Mountain View, CA 94043 |
| Contact | Kate Whitin |
| Correspondent | Kate Whitin HANSEN MEDICAL, INC. 800 E. MIDDLEFIELD ROAD Mountain View, CA 94043 |
| Product Code | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-23 |
| Decision Date | 2008-08-15 |
| Summary: | summary |