510(k) K050962 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
MERIT PRELUDE SHEATH INTRODUCER
| Applicant | Merit Medical Systems, Inc., South Jordan UT, US |
| Decision | Substantially Equivalent, May 6, 2005 |
| Received | Apr 18, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050962
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 14, 2009 | Merit Medical Systems, Inc. Merit Medical Systems, Inc. Prelude Pro Sheath Introducer REF/CAT No.: PRO-6F-11-035 Prelude PRO SHEATH INTRODUCER 6F 11 cm to provide access and facilitate the percutaneous introduction of various Terminated |
DRE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.