510(k) K123156 ยท NTE Temporary Carotid Catheter For Embolic Capture
GORE FLOW REVERSAL SYSTEM MODEL GFRS073
| Applicant | W. L. Gore & Associates, Inc., Phonix AZ, US |
| Decision | Substantially Equivalent, Dec 13, 2012 |
| Received | Oct 9, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K123156
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.