510(k) K111004 ยท DXX System, Catheter Control, Steerable
HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETER
| Applicant | Hansen Medical, Inc., Mountain View CA, US |
| Decision | Substantially Equivalent, May 29, 2012 |
| Received | Apr 11, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111004
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 25, 2016 | Hansen Medical Inc Magellan Robotic Catheter Accessory Kits,
Model number MACC 50 and MACC80.
Cardiology: The Hansen Medical Magellan System is a robotic control system that enables positioning and visualization of a M Terminated |
DXX | None listed |
| Apr 15, 2015 | Hansen Medical Inc Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites. Terminated |
DXX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.