510(k) K240486

PM2 System and ECGuide Connector by Piccolo Medical, Inc. — Product Code LJS

K240486 is an FDA 510(k) premarket notification submitted by Piccolo Medical, Inc. for the device "PM2 System and ECGuide Connector". The FDA issued a decision of Substantially Equivalent on September 8, 2024. The device falls under product code LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days), a Class II device regulated under 21 CFR 880.5970. Piccolo Medical, Inc. has at least 3 other 510(k) clearances on record.