510(k) K253799

SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R) by Pressure Products Medical Device Manufacturing, LLC — Product Code DXF

K253799 is an FDA 510(k) premarket notification submitted by Pressure Products Medical Device Manufacturing, LLC for the device "SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)". The FDA issued a decision of Substantially Equivalent on March 13, 2026. The device falls under product code DXF (Catheter, Septostomy), a Class II device regulated under 21 CFR 870.5175. Pressure Products Medical Device Manufacturing, LLC has at least 8 other 510(k) clearances on record.