The following data is part of a premarket notification filed by Hansen Medical, Inc. with the FDA for Hansen Medical Catheter Control System (ccs) And Accessories, Hansen Medical Steerable Guide Catheter (sgc) And Sheath.
| Device ID | K052480 |
| 510k Number | K052480 |
| Device Name: | HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL STEERABLE GUIDE CATHETER (SGC) AND SHEATH |
| Classification | System, Catheter Control, Steerable |
| Applicant | HANSEN MEDICAL, INC. 380 NORTH BERNARDO AVE. Mountain View, CA 94043 |
| Contact | Nina Peled |
| Correspondent | Nina Peled HANSEN MEDICAL, INC. 380 NORTH BERNARDO AVE. Mountain View, CA 94043 |
| Product Code | DXX |
| CFR Regulation Number | 870.1290 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-09 |
| Decision Date | 2007-05-02 |
| Summary: | summary |