510(k) K113110 ยท DYB Introducer, Catheter
AXERA ACCESS SYSTEM
| Applicant | Arstasis, Inc., Redwood City CA, US |
| Decision | Substantially Equivalent, Nov 9, 2011 |
| Received | Oct 20, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K113110
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.