510(k) K172950

TSN Transseptal Needle by Pressure Products Medical Device Manufacturing, LLC — Product Code DRC

K172950 is an FDA 510(k) premarket notification submitted by Pressure Products Medical Device Manufacturing, LLC for the device "TSN Transseptal Needle". The FDA issued a decision of Substantially Equivalent on February 21, 2018. The device falls under product code DRC (Trocar), a Class II device regulated under 21 CFR 870.1390. Pressure Products Medical Device Manufacturing, LLC has at least 8 other 510(k) clearances on record.