510(k) K031691 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
MERIT MAK (MINI ACCESS KIT)
| Applicant | Merit Medical Systems, Inc., South Jordan UT, US |
| Decision | Substantially Equivalent, Sep 3, 2003 |
| Received | Jun 2, 2003 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K031691
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 4, 2004 | Merit Medical Systems, Inc Merit MAK Mini Access Kit, 4 French (1.3mm) Terminated |
DRE | None listed |
| Aug 4, 2004 | Merit Medical Systems, Inc Merit MAK Mini Access Kit, 4 French (1.3mm) Terminated |
DRE | None listed |
| Aug 4, 2004 | Merit Medical Systems, Inc Merit MAK Mini Access Kit, 4 French (1.3mm) Terminated |
DRE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.