510(k) K024118 ยท KRA Catheter, Continuous Flush
ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, MODELS 105-5065 AND 105-5066
| Applicant | Micro Therapeutics, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Feb 3, 2003 |
| Received | Dec 16, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K024118
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 27, 2012 | Micro Therapeutics Inc, Dba Ev3 Neurovascular UltraFlow HPC Flow Directed Micro Catheter, Model # 105-5065.
Product Usage:
The UltraFlow HPC Flow Directed Micro Catheter is intended to access peripheral and neuro vasculature for the controlled s Terminated |
KRA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.