510(k) K201916 ยท DTZ Oxygenator, Cardiopulmonary Bypass
Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hollow Fiber oxygenator, Inspire 8M Hollow Fiber oxygenator
| Applicant | Sorin Group Italia S.R.L., Mirandola, IT |
| Decision | Substantially Equivalent, Aug 13, 2020 |
| Received | Jul 10, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K201916
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.