510(k) K191246 ยท DTZ Oxygenator, Cardiopulmonary Bypass
Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP)
| Applicant | Chalice Medical , Ltd., Worksop, GB |
| Decision | Substantially Equivalent, Feb 28, 2020 |
| Received | May 9, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191246
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.