510(k) K082613 ยท KRA Catheter, Continuous Flush
MERIT MICROCATHETER
| Applicant | Merit Medical Systems, Inc., South Jordan UT, US |
| Decision | Substantially Equivalent, Dec 30, 2008 |
| Received | Sep 8, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082613
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 31, 2014 | Merit Medical Systems, Inc. Merit Maestro Microcatheter, 2.4F 130cm Straight, REF28MC24130ST, Rx Only, Non-pyrogenic Sterile if package is unopened or undamaged. Terminated |
KRA | None listed |
| Dec 31, 2013 | Merit Medical Systems, Inc. Catheter, Continuous Flush
The Merit Microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the subselective region has been accessed, the microca Terminated |
KRA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.