510(k) K180448 ยท DTZ Oxygenator, Cardiopulmonary Bypass
INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with Integrated Arterial Filter; INSPIRE 8M Hollow Fiber Oxygenator; INSPIRE 8F M Hollow Fiber Oxygenator with Integrated Arterial Filter
| Applicant | Sorin Group Italia S.R.L., Mirandola, IT |
| Decision | Substantially Equivalent, Mar 15, 2018 |
| Received | Feb 13, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K180448
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.