510(k) K033670 ยท DQY Catheter, Percutaneous
GORE TRI-LOBE BALLOON CATHETER
| Applicant | W. L. Gore & Associates, Inc., Flagstaff AZ, US |
| Decision | Substantially Equivalent, May 5, 2004 |
| Received | Nov 24, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033670
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.