FDA cleared the CROSSLEAD Standard 035 and CROSSLEAD Stiff 035 from Filmecc Co., Ltd. on Sep 3, 2026 under K261281, a traditional 510(k). The device falls under product code DQX, Wire, Guide, Catheter, regulated at 21 CFR 870.1330 as a Class 2 device. The review panel was Cardiovascular.
FDA logged the submission as received on Apr 17, 2026. The decision came 139 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.
This is the only decision on file for Filmecc Co., Ltd. in the last 12 months of the tracker.