510(k) K090365 ยท DXX System, Catheter Control, Steerable
HANSEN MEDICAL ARTISAN S CONTROL CATHETER
| Applicant | Hansen Medical, Inc., Mountain View CA, US |
| Decision | Unknown, May 7, 2009 |
| Received | Feb 13, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K090365
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 6, 2010 | Hansen Medical Inc Artisan brand Extend Control Catheter; An Steerable Guide Catheter; Component of Sensei X Robotic Catheter System; Model Number: 07546; Distributed and Manufactured by Hansen Medical, Inc, Mountain Terminated |
DXX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.