510(k) K162322 ยท DYB Introducer, Catheter
the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model
| Applicant | Access Scientific, LLC, San Diego CA, US |
| Decision | Substantially Equivalent, Nov 17, 2016 |
| Received | Aug 19, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162322
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.