510(k) K132947 ยท KRA Catheter, Continuous Flush
DIREXION AND DIREXION HI-FLO TORQUEABLE MICROCATHETERS
| Applicant | Boston Scientific Corp, Maple Grove MN, US |
| Decision | Substantially Equivalent, Oct 18, 2013 |
| Received | Sep 19, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K132947
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.