ClearanceBrief
510(k) K140745 ยท MAV Syringe, Balloon Inflation

ENCORE 26 ADVANTAGE KIT

ApplicantBoston Scientific Corp, Maple Grove MN, US
DecisionUnknown, Apr 17, 2014
ReceivedMar 25, 2014
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K140745

DateFirm and productCodeLinked 510(k)
Sep 5, 2025Boston Scientific Corporation
Boston Scientific Encore Advantage Kit, Material Numbers (UPN): 1. H74904527011; 2. H74904527052. (Interventional Cardiology and Peripheral Interventions)
Open, Classified
MAVNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.