510(k) K201057 ยท QHW Single Lumen Ecmo Cannula
Bio-Medicus Life Support Catheter and Introducer
| Applicant | Medtronic, Inc., Mounds View MN, US |
| Decision | Substantially Equivalent, Jan 14, 2022 |
| Received | Apr 21, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201057
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.