510(k) K242597

CROSSLEAD 0.018inch by Asahi Intecc Co., Ltd. — Product Code DQX

K242597 is an FDA 510(k) premarket notification submitted by Asahi Intecc Co., Ltd. for the device "CROSSLEAD 0.018inch". The FDA issued a decision of Substantially Equivalent on March 5, 2025. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Asahi Intecc Co., Ltd. has at least 10 other 510(k) clearances on record.