510(k) K973654 ยท LHI Set, I.V. Fluid Transfer
VIAL-MATE RECONSTITUTION DEVICE (2B8071)
| Applicant | Baxter Healthcare Corp, Round Lake IL, US |
| Decision | Substantially Equivalent, Oct 24, 1997 |
| Received | Sep 25, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973654
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 26, 2013 | Baxter Healthcare Corp. Baxter, VIAL-MATE Adaptor, 2B8071, Rx Only, STERILE R, Baxter Healthcare Corporation, Deerfield, IL 30015 USA
The VIAL-MATE is reconstitution device labeled for use with 20 mm drug vials and 50mL, 1 Terminated |
LHI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.