510(k) K231279

Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mm by Ablative Solutions, Inc. — Product Code KRA

K231279 is an FDA 510(k) premarket notification submitted by Ablative Solutions, Inc. for the device "Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mm". The FDA issued a decision of Substantially Equivalent on July 5, 2023. The device falls under product code KRA (Catheter, Continuous Flush), a Class II device regulated under 21 CFR 870.1210. Ablative Solutions, Inc. has at least 1 other 510(k) clearance on record.