510(k) K160254 ยท DYB Introducer, Catheter
GORE DrySeal Flex Introducer Sheath
| Applicant | W. L. Gore & Associates, Inc., Flagstaff AZ, US |
| Decision | Substantially Equivalent, May 12, 2016 |
| Received | Feb 1, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160254
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 18, 2019 | W. L. Gore & Associates Inc. Gore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile. The responsible firm on the label is W. L. Gore & Associates, Inc., Flagstaff, AZ. Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.