510(k) K190690 ยท DTZ Oxygenator, Cardiopulmonary Bypass
INSPIRE 7 Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir, INSPIRE 7M Hollow Fiber Oxygenator, INSPIRE 7 Dual Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir
| Applicant | Sorin Group Italia S.R.L., Mirandola, IT |
| Decision | Substantially Equivalent, Apr 13, 2019 |
| Received | Mar 18, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K190690
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.