510(k) K213442 ยท KRA Catheter, Continuous Flush
Extroducer Infusion Catheter System
| Applicant | SmartWise Sweden AB, Tullinge, SE |
| Decision | Substantially Equivalent, Jun 10, 2022 |
| Received | Oct 25, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213442
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.