510(k) K964061 ยท LYK Angioscope
GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD)
| Applicant | W. L. Gore & Associates, Inc., Flagstaff AZ, US |
| Decision | Substantially Equivalent, Feb 20, 1997 |
| Received | Oct 10, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964061
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.