510(k) K883718 ยท FPK Tubing, Fluid Delivery
MERIT HI-FLEX(TM)
| Applicant | Merit Medical Systems, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Jan 30, 1989 |
| Received | Aug 31, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K883718
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 12, 2025 | Merit Medical Systems, Inc. High Pressure Tubing: REF: 502211002, HP9720E/C, HP9721E/C Open, Classified |
FPK | None listed |
| Apr 3, 2014 | Merit Medical Systems, Inc. Pressure Monitoring Tubing, PM6006. Pressure Monitoring Tubing (PM series) is used between the manifold and transducer as a conduit to transmit the fluid pressure of the patient to the pressure tran Terminated |
OBI | None listed |
| Mar 6, 2003 | Merit Medical Systems, Inc Custom Angiographic Kit. Terminated |
DQO | None listed |
| Mar 6, 2003 | Merit Medical Systems, Inc Custom Angiographic Kit Terminated |
DQO | None listed |
| Mar 6, 2003 | Merit Medical Systems, Inc Custom Angiographic Kit Terminated |
DQO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.