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FDA 510(k)

Piccolo Medical SmartPICC System

K-Number: K200037 · 2021-01-22

ApplicantPiccolo Medical, Inc.
Decision Date2021-01-22
Product CodeLJS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Piccolo Medical SmartPICC System is a medical device manufactured by Piccolo Medical, Inc.. It received FDA 510(k) clearance on 2021-01-22 under approval number K200037. 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 Piccolo Medical SmartPICC System?

Piccolo Medical SmartPICC System is a medical device that received FDA 510(k) clearance on 2021-01-22. It is manufactured by Piccolo Medical, Inc.. The 510(k) number is K200037.

When was Piccolo Medical SmartPICC System approved by the FDA?

Piccolo Medical SmartPICC System received FDA 510(k) clearance on 2021-01-22, under approval number K200037.

What company makes Piccolo Medical SmartPICC System?

Piccolo Medical SmartPICC System is manufactured by Piccolo Medical, Inc..

What is the FDA product code for Piccolo Medical SmartPICC System?

The FDA product code for Piccolo Medical SmartPICC System is LJS.

Related Clinical Trials

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Related PubMed Literature

PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) PMID: 41879133 Medical Device Regulation - Who Does the FDA Serve? The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026)

Other Devices by Piccolo Medical, Inc.

K240486PM2 System and ECGuide Connector 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.

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