510(k) K212719

Micro Catheter and Guidewire System by Suzhou Hengrui Hongyuan Medical Co., Ltd. — Product Code KRA

K212719 is an FDA 510(k) premarket notification submitted by Suzhou Hengrui Hongyuan Medical Co., Ltd. for the device "Micro Catheter and Guidewire System". The FDA issued a decision of Substantially Equivalent on April 11, 2022. The device falls under product code KRA (Catheter, Continuous Flush), a Class II device regulated under 21 CFR 870.1210. Suzhou Hengrui Hongyuan Medical Co., Ltd. has at least 1 other 510(k) clearance on record.