510(k) K073035 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
PRELUDE AND PRELUDE PRO SHEATH INTRODUCERS
| Applicant | Merit Medical Systems, Inc., South Jordan UT, US |
| Decision | Substantially Equivalent, Nov 20, 2007 |
| Received | Oct 29, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K073035
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.