510(k) K121504 ยท DYB Introducer, Catheter
SUPER SHEATH INTRODUCER SHEATH AND SUPER SHEATH INTRODUCER SHEATH SETS
| Applicant | Togo Medikit Co., Ltd., Austin TX, US |
| Decision | Substantially Equivalent, Sep 27, 2012 |
| Received | May 21, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121504
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.