510(k) K210562

HRSpheres Narrow-Size Embolic Microspheres by Suzhou Hengrui Hongyuan Medical Co., Ltd. — Product Code KRD

K210562 is an FDA 510(k) premarket notification submitted by Suzhou Hengrui Hongyuan Medical Co., Ltd. for the device "HRSpheres Narrow-Size Embolic Microspheres". The FDA issued a decision of Substantially Equivalent on October 1, 2021. The device falls under product code KRD (Device, Vascular, For Promoting Embolization), a Class II device regulated under 21 CFR 870.3300. Suzhou Hengrui Hongyuan Medical Co., Ltd. has at least 1 other 510(k) clearance on record.