510(k) K243484

PM2+ System and SmartPICC Stylet by Piccolo Medical, Inc. — Product Code LJS

K243484 is an FDA 510(k) premarket notification submitted by Piccolo Medical, Inc. for the device "PM2+ System and SmartPICC Stylet". The FDA issued a decision of Substantially Equivalent on May 29, 2025. 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.