HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL STEERABLE GUIDE CATHETER (SGC) AND SHEATH
FDA 510(k) clearance K052480 · decided 2007-05-02
Clearance details
- K-number
- K052480
- Device name
- HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL STEERABLE GUIDE CATHETER (SGC) AND SHEATH
- Applicant
- Hansen Medical, Inc.
- Decision
- Unknown
- Date received
- 2005-09-09
- Decision date
- 2007-05-02
- Days to decision
- 600 days
- Clearance type
- Traditional
- Product code
- DXX
- Device class
- 2
- Regulation number
- 870.1290
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mountain View, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Sensei X Robotic Catheter System, model numbers 02057 and 08257. - Set up joint (SUJ)mecha recall (Z-0896-2015) | Hansen Medical Inc | 2014-12-30 |
| Artisan Control Catheter, model number 04454, manufactured by Hansen Medical, Inc., Mounta recall (Z-2106-2008) | Hansen Medical Inc | 2008-09-11 |