510(k) K241042

SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198) by Pressure Products Medical Device Manufacturing, LLC — Product Code DRC

K241042 is an FDA 510(k) premarket notification submitted by Pressure Products Medical Device Manufacturing, LLC for the device "SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)". The FDA issued a decision of Substantially Equivalent on May 17, 2024. 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.