510(k) K140028 ยท DYB Introducer, Catheter
GALT VTI LOW INSERTION VALVE TEARAWAY INTRODUCER
| Applicant | Galt Medical Corp., Garland TX, US |
| Decision | Substantially Equivalent, Aug 21, 2014 |
| Received | Jan 6, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140028
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.