510(k) K102714 ยท KRD Device, Vascular, For Promoting Embolization
COMPLEX HELICAL 18, MULTI-LOOP 18, FIGURE 8-18, STRAIGHT 18 FIBERED PLATINUM COILS, VORTX -18, VORTX 35 & 2D HELICAL
| Applicant | Boston Scientific Corp, Maple Grove MN, US |
| Decision | Substantially Equivalent, Feb 11, 2011 |
| Received | Sep 20, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102714
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.