510(k) K172893

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

K172893 is an FDA 510(k) premarket notification submitted by Pressure Products Medical Device Manufacturing, LLC for the device "SafeSept Needle Free Transseptal Guidewire". The FDA issued a decision of Substantially Equivalent on December 21, 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.