510(k) K183066 · DYB Introducer, Catheter
The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD Technology-3 Fr, 4 Fr, and 5 Fr Model
| Applicant | Access Scientific, LLC, San Diego CA, US |
| Decision | Substantially Equivalent, Jul 25, 2019 |
| Received | Nov 5, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183066
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.