SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057
FDA 510(k) clearance K091808 · decided 2009-09-10
Clearance details
- K-number
- K091808
- Device name
- SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057
- Applicant
- Hansen Medical, Inc.
- Decision
- Unknown
- Date received
- 2009-06-18
- Decision date
- 2009-09-10
- Days to decision
- 84 days
- Clearance type
- Special
- 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 |