ClearanceBrief
510(k) K100462 ยท MCW Catheter, Peripheral, Atherectomy

JETSTREAM G3 L SYSTEM, PV CONSOLE, MODELS PV31400, PV31300, PVCN100

ApplicantPathway Medical Technologies, Inc., Kirkland WA, US
DecisionSubstantially Equivalent, May 19, 2010
ReceivedFeb 18, 2010
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K100462

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.