ClearanceBrief
510(k) K001222 ยท FGE Stents, Drains And Dilators For The Biliary Ducts

OTW MEGALINK SDS BILLIARY STENT SYSTEM, MODELS 1005509-18, 1005510-18, 1005511-18, 1005512-18, 1005509-28, 1005510-28, 1

ApplicantGuidant Corp., Santa Clara CA, US
DecisionUnknown, May 17, 2000
ReceivedApr 17, 2000
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K001222

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.