510(k) K083523 ยท DXT Injector And Syringe, Angiographic
MONARCH COMPAK INFLATION SYRINGE AND UNIVERSAL FLUID DISPENSING SYRINGE
| Applicant | Merit Medical Systems, Inc., South Jordan UT, US |
| Decision | Substantially Equivalent, Feb 4, 2009 |
| Received | Nov 26, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K083523
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 11, 2024 | Merit Medical Systems, Inc. Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7802/C, IN7852/C, IN7130/C Open, Classified |
DXT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.