510(k) K122321 ยท MAV Syringe, Balloon Inflation
BASIXCONPAK ANALOG INFLATION SYRINGE
| Applicant | Merit Medical Ireland, Ltd., South Jordan UT, US |
| Decision | Substantially Equivalent, Dec 19, 2012 |
| Received | Aug 1, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122321
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 25, 2016 | Merit Medical Systems, Inc. Merit Inflation Syringe Kit. Catalog Number KOS-02857 Terminated |
MAV | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.