510(k) K955869 ยท MAV Syringe, Balloon Inflation
SCIMED ENCORE 26 INFLATION DEVICE/ENCORE 30 INFLATION DEVICE
| Applicant | Scimed Life Systems, Inc., Maple Grove MN, US |
| Decision | Substantially Equivalent, Mar 22, 1996 |
| Received | Dec 26, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955869
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 15, 2017 | Boston Scientific Corporation Encore(TM) 26 Inflation Device, REF Catalog Nos.: (a) H74904526011, (b) M001151050, (c) M00566670, (d) M0067101140 Terminated |
MAV | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.