510(k) K261281

CROSSLEAD Standard 035 and CROSSLEAD Stiff 035 by Filmecc Co., Ltd. — Product Code DQX

K261281 is an FDA 510(k) premarket notification submitted by Filmecc Co., Ltd. for the device "CROSSLEAD Standard 035 and CROSSLEAD Stiff 035". The FDA issued a decision of Substantially Equivalent on September 3, 2026. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Filmecc Co., Ltd. has at least 5 other 510(k) clearances on record.