510(k) K212625

PathBuilder Transseptal Needle by Shanghai Microport EP Medtech Co., Ltd. — Product Code DRC

K212625 is an FDA 510(k) premarket notification submitted by Shanghai Microport EP Medtech Co., Ltd. for the device "PathBuilder Transseptal Needle". The FDA issued a decision of Substantially Equivalent on March 23, 2022. The device falls under product code DRC (Trocar), a Class II device regulated under 21 CFR 870.1390. Shanghai Microport EP Medtech Co., Ltd. has at least 3 other 510(k) clearances on record.