510(k) K860515 ยท LBW Set, Dialysis, Single Needle (Co-Axial Flow)
DUAL LUMEN NEEDLE (PRODUCT CHANGE)
| Applicant | Quinton, Inc., Seattle WA, US |
| Decision | Substantially Equivalent, Mar 4, 1986 |
| Received | Feb 11, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K860515
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.