510(k) K120428 ยท DYB Introducer, Catheter
GORE DRYSEAL SHEATH
| Applicant | W. L. Gore & Associates, Inc., Flagstaff AZ, US |
| Decision | Substantially Equivalent, Apr 20, 2012 |
| Received | Feb 13, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K120428
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.