510(k) K242248

Introducer Sheath Kits by Beijing Demax Medical Technology Co.,Ltd — Product Code DYB

K242248 is an FDA 510(k) premarket notification submitted by Beijing Demax Medical Technology Co.,Ltd for the device "Introducer Sheath Kits". The FDA issued a decision of Substantially Equivalent on August 22, 2024. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Beijing Demax Medical Technology Co.,Ltd has at least 3 other 510(k) clearances on record.