510(k) K161733 ยท DTN Reservoir, Blood, Cardiopulmonary Bypass
INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C
| Applicant | Sorin Group Italia S.R.L., Mirandola, IT |
| Decision | Substantially Equivalent, Mar 8, 2017 |
| Received | Jun 23, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161733
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.