510(k) K123344 ยท FPA Set, Administration, Intravascular
K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET (PAIS)
| Applicant | Kawasumi Laboratories, Inc., Kenosha WI, US |
| Decision | Substantially Equivalent, Mar 7, 2013 |
| Received | Oct 31, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123344
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.