510(k) K162601 ยท FPA Set, Administration, Intravascular
Infusion Set for Single Use
| Applicant | Shinva Ande Healthcare Apparatus Co., Ltd., Zibo, CN |
| Decision | Substantially Equivalent, May 31, 2017 |
| Received | Sep 19, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162601
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.