510(k) K201642 ยท DTZ Oxygenator, Cardiopulmonary Bypass
Paragon Adult Maxi PMP Oxygenator with Tubing Pack
| Applicant | Chalice Medical , Ltd., Worksop, GB |
| Decision | Substantially Equivalent, Sep 18, 2020 |
| Received | Jun 17, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201642
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.