510(k) K141254 ยท FMG Stopcock, I.V. Set
ELCAM STOPCOCKS AND MANIFOLDS
| Applicant | Elcam Medical Acal, -, IL |
| Decision | Substantially Equivalent, Jul 30, 2014 |
| Received | May 14, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K141254
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 10, 2018 | Smiths Medical ASD Inc. medfusion Stopcock, 1-way and 4-way, Model Numbers (REF):
a. 081-101BE
b. 081-101GE
c. 081-101GEE
d. 081-101NE
e. 081-102NE
f. 081-102RE
g. 089-101E
h. 888-101NE
i. 081-102GEE
j. 888-101BE
k. 888-101G Terminated |
FMG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.