510(k) K132263 ยท DYB Introducer, Catheter
AXERA 2 ACCESS SYSTEM
| Applicant | Arstasis, Inc., Redwood City CA, US |
| Decision | Substantially Equivalent, Aug 19, 2013 |
| Received | Jul 22, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K132263
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.