510(k) K190233 ยท FPA Set, Administration, Intravascular
K-Shield Advantage Port Access Infusion Set (PAIS)
| Applicant | Kawasumi Laboratories, Inc., Tokyo, JP |
| Decision | Substantially Equivalent, May 2, 2019 |
| Received | Feb 6, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K190233
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.