510(k) K212626

PathBuilder Transseptal Guiding Introducer by Shanghai Microport EP Medtech Co., Ltd. — Product Code DYB

K212626 is an FDA 510(k) premarket notification submitted by Shanghai Microport EP Medtech Co., Ltd. for the device "PathBuilder Transseptal Guiding Introducer". The FDA issued a decision of Substantially Equivalent on March 23, 2022. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Shanghai Microport EP Medtech Co., Ltd. has at least 3 other 510(k) clearances on record.