510(k) K091584 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
MERIT MAK (MINI ACCESS KIT) WITH PALLADIUM TIP GUIDE WIRE
| Applicant | Merit Medical Systems, Inc., South Jordan UT, US |
| Decision | Substantially Equivalent, Oct 9, 2009 |
| Received | Jun 2, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091584
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.