510(k) K113628 ยท DXX System, Catheter Control, Steerable
AMIGO REMOTE CATHETER SYSTEM (RCS) & ACCESSORIES
| Applicant | Catheter Robotics, Inc., Mount Olive NJ, US |
| Decision | Substantially Equivalent, Jun 12, 2012 |
| Received | Dec 8, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113628
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.