510(k) K083300 ยท NTE Temporary Carotid Catheter For Embolic Capture
GORE FLOW REVERSAL SYSTEM
| Applicant | W. L. Gore & Associates, Inc., Flagstaff AZ, US |
| Decision | Substantially Equivalent, Feb 4, 2009 |
| Received | Nov 10, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083300
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.