510(k) K100789 ยท DRA Catheter, Steerable
MODIFICATON TO: STEERABLE GUIDE CATHETER, MODEL SGC01ST
| Applicant | Evalve, Inc., Menlo Park CA, US |
| Decision | Substantially Equivalent, Apr 21, 2010 |
| Received | Mar 22, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K100789
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.