510(k) K130209 ยท DTZ Oxygenator, Cardiopulmonary Bypass
INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDHELL RESERVOIR, INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED
| Applicant | Sorin Group Italia S.R.L., Arvada CO, US |
| Decision | Substantially Equivalent, Feb 12, 2013 |
| Received | Jan 29, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K130209
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 13, 2018 | LivaNova USA Inspire 6 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050713
The intended uses for the two elements that constitute the oxygenator/reservoir integrated devices are: INSPIRE 6M Hollo Terminated |
DTZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.