510(k) K070770 ยท MJN Catheter, Intravascular Occluding, Temporary
GORE BALLOON SHEATH
| Applicant | W. L. Gore & Associates, Inc., Pleasanton CA, US |
| Decision | Substantially Equivalent, Jun 29, 2007 |
| Received | Mar 20, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070770
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.