510(k) K130433 ยท DTZ Oxygenator, Cardiopulmonary Bypass
INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR, INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATE
| Applicant | Sorin Group Italia S.R.L., Arvada CO, US |
| Decision | Substantially Equivalent, Mar 20, 2013 |
| Received | Feb 21, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K130433
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 13, 2018 | LivaNova USA Inspire 8 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050714
The intended uses for the two elements that constitute the oxygenator/reservoir integrated devices are: INSPIRE 8M Holl Terminated |
DTZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.