510(k) K221707

SafeSept® Transseptal Guidewire (SS-140) by Pressure Products Medical Device Manufacturing, LLC — Product Code DRC

K221707 is an FDA 510(k) premarket notification submitted by Pressure Products Medical Device Manufacturing, LLC for the device "SafeSept® Transseptal Guidewire (SS-140)". The FDA issued a decision of Substantially Equivalent on September 14, 2022. 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.