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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Piccolo Medical, Inc.. It received FDA 510(k) clearance on 2025-05-29 under 510(k) 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. The listed applicant is Piccolo Medical, Inc.. The 510(k) number is K243484.

When did PM2+ System and SmartPICC Stylet receive FDA 510(k) clearance?

PM2+ System and SmartPICC Stylet received FDA 510(k) clearance on 2025-05-29, under 510(k) number K243484.

Who is the listed applicant for PM2+ System and SmartPICC Stylet?

The FDA 510(k) record lists Piccolo Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Piccolo Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252792PM2™ System with ECGuide™ ConnectorK240486PM2 System and ECGuide ConnectorK200037Piccolo Medical SmartPICC System

Related Devices (Code: LJS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260929Neonav ECG Tip Location SystemNavi Medical TechnologiesK252373BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve TechnologySpectrum VascularK252792PM2™ System with ECGuide™ ConnectorPiccolo Medical, Inc.K243458HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); HydrAccess Vascular, Inc.K251212Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)Access Vascular, Inc.K241587pilot TLSVygon Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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