510(k) K034036 ยท KRA Catheter, Continuous Flush
MARATHON FLOW DIRECTED MICRO CATHETER, MODEL 105-5055
| Applicant | Micro Therapeutics, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Feb 13, 2004 |
| Received | Dec 29, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K034036
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 27, 2012 | Micro Therapeutics Inc, Dba Ev3 Neurovascular Marathon Flow Directed Micro Catheter, Model #105-5055.
Product Usage: The Marathon Flow Directed Micro Catheter is intended to access the peripheral and neuro vasculature for the controlled selectiv Terminated |
KRA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.