510(k) K964853 ยท KPE Container, I.V.
INTRAVIA CONTAINER, EMPTY
| Applicant | Baxter Healthcare Corp, Round Lake IL, US |
| Decision | Substantially Equivalent, Mar 31, 1997 |
| Received | Dec 3, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964853
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2018 | Baxter Healthcare Corporation Empty IntraVia Container with Non-DEHP Fluid Path, 500mL
Containers are intended for use in the preparation and administration of drug admixtures. Terminated |
KPE | None listed |
| Oct 31, 2014 | Baxter Healthcare Corp Baxter 2B8011 Empty INTRA VIA Container with PVC Ports, Sterile fluid path, 150 ml, Admixture Products and Accessories.
The lntraVia Empty Plastic Container is intended for use in the preparation an Terminated |
KPE | None listed |
| Oct 31, 2014 | Baxter Healthcare Corp Baxter 2B8013 Empty INTRA VIA Container with PVC Ports (Sterile, nonpyrogenic fluid path) ,500 ml. Admixture Products and Accessories
The lntraVia Empty Plastic Container is intended for use in th Terminated |
KPE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.