510(k) K123135 ยท DYB Introducer, Catheter
AXERA 2 ACCESS SYSTEM MODEL AXE200
| Applicant | Arstasis, Inc., Redwood City CA, US |
| Decision | Substantially Equivalent, Jan 28, 2013 |
| Received | Oct 5, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123135
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.