510(k) K100892 ยท KRA Catheter, Continuous Flush
RENEGADE HI-FLO FATHOM KIT MODEL M001182XXX
| Applicant | Boston Scientific Corp, Maple Grove MN, US |
| Decision | Substantially Equivalent, Apr 12, 2010 |
| Received | Mar 31, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K100892
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.