510(k) K173577 ยท LHI Set, I.V. Fluid Transfer
Guarded Luer Connector
| Applicant | International Medical Industries, Inc., Pompano Beach FL, US |
| Decision | Substantially Equivalent, Jun 7, 2018 |
| Received | Nov 20, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173577
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 7, 2023 | International Medical Industries, Inc. Prep-Fill Guarded Luer Connector (GLC):
a. Part Number 57-400, Female Lock - Female Lock Guarded Luer Connector, Sterile;
b. Part number 57-400W, Female Lock - Female Lock Guarded Luer Connector, Open, Classified |
LHI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.