510(k) K992231 ยท QEY Mechanical Thrombolysis Catheter
FOUNTAIN Infusion Catheter and Occluding Guide Wire
| Applicant | Merit Medical Systems, Inc., South Jordan UT, US |
| Decision | Substantially Equivalent, Jul 23, 1999 |
| Received | Jul 2, 1999 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K992231
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 2, 2024 | Merit Medical Systems, Inc. Fountain, REF: IS4-135-30 and IS4-90-10, CE2797, STERILEEO, Rx ONLY Open, Classified |
QEY | None listed |
| Sep 11, 2008 | Merit Medical Systems, Inc. Fountain Infusion System, 4F, REF IS4-90-50, Sterile, Merit Medical Systems, Inc., South Jordan, Utah 84095. Continuous flush catheter intended to administer infusions of various therapeutic solution Terminated |
KRA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.