PM2+ System and SmartPICC Stylet
K-Number: K243484 · 2025-05-29
ApplicantPiccolo Medical, Inc.
Decision Date2025-05-29
Product CodeLJS
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
PM2+ System and SmartPICC Stylet is a medical device manufactured by Piccolo Medical, Inc.. It received FDA 510(k) clearance on 2025-05-29 under approval number K243484. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PM2+ System and SmartPICC Stylet?
PM2+ System and SmartPICC Stylet is a medical device that received FDA 510(k) clearance on 2025-05-29. It is manufactured by Piccolo Medical, Inc.. The 510(k) number is K243484.
When was PM2+ System and SmartPICC Stylet approved by the FDA?
PM2+ System and SmartPICC Stylet received FDA 510(k) clearance on 2025-05-29, under approval number K243484.
What company makes PM2+ System and SmartPICC Stylet?
PM2+ System and SmartPICC Stylet is manufactured by Piccolo Medical, Inc..
What is the FDA product code for PM2+ System and SmartPICC Stylet?
The FDA product code for PM2+ System and SmartPICC Stylet is LJS.
Other Devices by Piccolo Medical, Inc.
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K151985PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH CatheterC.R. Bard, Inc.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.