510(k) K243733

SION blue PLUS by Asahi Intecc Co., Ltd. — Product Code DQX

K243733 is an FDA 510(k) premarket notification submitted by Asahi Intecc Co., Ltd. for the device "SION blue PLUS". The FDA issued a decision of Substantially Equivalent on April 2, 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.