510(k) K093750 ยท KRA Catheter, Continuous Flush
ECHELON MICRO CATHETER, MARATHON MICRO CATHETER, NAUTICA MICRO CATHETER ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, REBA
| Applicant | Ev3, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Dec 9, 2009 |
| Received | Dec 7, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K093750
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 30, 2022 | Micro Therapeutics, Inc. Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx Only Open, Classified |
KRA | None listed |
| Jun 30, 2022 | Micro Therapeutics, Inc. Echelon -14 Micro Catheter, REF: 105-5092-150, sterile EO, Rx Only Open, Classified |
KRA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.