510(k) K052480 ยท DXX System, Catheter Control, Steerable
HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL STEERABLE GUIDE CATHETER (SGC) AND SHEATH
| Applicant | Hansen Medical, Inc., Mountain View CA, US |
| Decision | Unknown, May 2, 2007 |
| Received | Sep 9, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052480
| 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 |
| Sep 11, 2008 | Hansen Medical Inc Artisan Control Catheter, model number 04454, manufactured by Hansen Medical, Inc., Mountain View, CA. Steerable guide catheter for human use intended to facilitate manipulation, positioning and cont Terminated |
DRA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.