FDA 510(k)

PM2 System and ECGuide Connector

K-Number: K240486 · 2024-09-08

Decision Date2024-09-08

Product CodeLJS

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

PM2 System and ECGuide Connector is a medical device manufactured by Piccolo Medical, Inc.. It received FDA 510(k) clearance on 2024-09-08 under approval number K240486. 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 ECGuide Connector?

PM2 System and ECGuide Connector is a medical device that received FDA 510(k) clearance on 2024-09-08. It is manufactured by Piccolo Medical, Inc.. The 510(k) number is K240486.

When was PM2 System and ECGuide Connector approved by the FDA?

PM2 System and ECGuide Connector received FDA 510(k) clearance on 2024-09-08, under approval number K240486.

What company makes PM2 System and ECGuide Connector?

PM2 System and ECGuide Connector is manufactured by Piccolo Medical, Inc..

What is the FDA product code for PM2 System and ECGuide Connector?

The FDA product code for PM2 System and ECGuide Connector is LJS.

Other Devices by Piccolo Medical, Inc.

K200037Piccolo Medical SmartPICC System K252792PM2 System with ECGuide Connector K243484PM2+ System and SmartPICC Stylet

Related Devices (Code: LJS)

K160925VPS Rhythm Device with TipTracker TechnologyArrow International, Inc. (A Subsidiary of Teleflex, Inc.) K162443PowerPICC Provena CathetersC.R. Bard, Inc. K161496Turbo-Flo PICC SetsCook Incorporated K161765CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex K153469Cathtong I PICC CatheterL&Z Us, Inc. 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.