510(k) K904855 ยท LHI Set, I.V. Fluid Transfer
ADD-A-VIAL
| Applicant | Kendall Mcgaw Laboratories, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Nov 19, 1990 |
| Received | Oct 29, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K904855
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 27, 2013 | B. Braun Medical, Inc. 20mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC2000
Product is intended for fluid transfer between a Partial Additive Bag (PAB(R)) container and a drug vial. Terminated |
LHI | None listed |
| Nov 27, 2013 | B. Braun Medical, Inc. 13mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC1300
Product is intended for fluid transfer between a Partial Additive Bag (PAB(R)) container and a drug vial. Terminated |
LHI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.