510(k) K180919 ยท DQY Catheter, Percutaneous
GORE Tri-Lumen Catheter
| Applicant | W. L. Gore and Associates, Inc., Flagstaff AZ, US |
| Decision | Substantially Equivalent, Oct 5, 2018 |
| Received | Apr 9, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180919
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.