510(k) K123214 ยท MAV Syringe, Balloon Inflation
ENCORE 26 ADVANTAGE KIT
| Applicant | Boston Scientific Corp, Maple Grove MN, US |
| Decision | Substantially Equivalent, Nov 13, 2012 |
| Received | Oct 15, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K123214
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.