510(k) K190328 ยท KPE Container, I.V.
HCT Empty EVA Container Pack
| Applicant | Health Care Technologies, Ashland MA, US |
| Decision | Substantially Equivalent, Aug 15, 2019 |
| Received | Feb 13, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190328
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2023 | Stradis Healthcare HCT 500mL BAGS, 2 Port, Sterile, Triple Packaged, 10 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology. Open, Classified |
KPE | None listed |
| Jan 11, 2023 | Stradis Healthcare HCT 50mL EVA BAGS, 2 Port, Sterile, Tripple Packaged, 20 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology. Open, Classified |
KPE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.