510(k) K102168 ยท DXX System, Catheter Control, Steerable
SENSEI X ROBOTIC CATHETER SYSTEM
| Applicant | Hansen Medical, Inc., Mountain View CA, US |
| Decision | Substantially Equivalent, Oct 22, 2010 |
| Received | Aug 2, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K102168
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 30, 2014 | Hansen Medical Inc Sensei X Robotic Catheter System, model numbers 02057 and 08257. - Set up joint (SUJ)mechanical clamp that secures the SUJ to the catheter laboratory table.
Product Usage:
The Sensei X Robotic Cat Terminated |
DXX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.