510(k) K121234 ยท DYB Introducer, Catheter
GORE(R) DRYSEAL SHEATH WITH HYDROPHILIC COATING
| Applicant | W. L. Gore & Associates, Inc., Flagstaff AZ, US |
| Decision | Substantially Equivalent, Nov 20, 2012 |
| Received | Apr 24, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121234
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.