510(k) K170671

SafeSept Transseptal Guidewire by Pressure Products Medical Device Manufacturing, LLC — Product Code DRC

K170671 is an FDA 510(k) premarket notification submitted by Pressure Products Medical Device Manufacturing, LLC for the device "SafeSept Transseptal Guidewire". The FDA issued a decision of Substantially Equivalent on October 20, 2017. 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.