510(k) K081799 ยท DQY Catheter, Percutaneous
GORE TRI-LOBE BALLOON CATHETER
| Applicant | W. L. Gore & Associates, Inc., Flagstaff AZ, US |
| Decision | Substantially Equivalent, Oct 3, 2008 |
| Received | Jun 25, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081799
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.