510(k) K232934

Sunsphere by Hangzhou Yangshun Medical Technology Co.,Ltd — Product Code KRD

K232934 is an FDA 510(k) premarket notification submitted by Hangzhou Yangshun Medical Technology Co.,Ltd for the device "Sunsphere". The FDA issued a decision of Substantially Equivalent on May 30, 2024. The device falls under product code KRD (Device, Vascular, For Promoting Embolization), a Class II device regulated under 21 CFR 870.3300.