FDA 510(k)

PM2™ System with ECGuide™ Connector

Número K: K252792 · 2025-11-17

Data da decisão2025-11-17

Código do produtoLJS

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

PM2™ System with ECGuide™ Connector 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 2025-11-17 under 510(k) number K252792. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the PM2™ System with ECGuide™ Connector?

PM2™ System with ECGuide™ Connector is a medical device that received FDA 510(k) clearance on 2025-11-17. The listed applicant is Piccolo Medical, Inc.. The 510(k) number is K252792.

When did PM2™ System with ECGuide™ Connector receive FDA 510(k) clearance?

PM2™ System with ECGuide™ Connector received FDA 510(k) clearance on 2025-11-17, under 510(k) number K252792.

Who is the listed applicant for PM2™ System with ECGuide™ Connector?

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 with ECGuide™ Connector?

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

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Outros registros que listam Piccolo Medical, Inc. como candidato(a)

K243484PM2+ System and SmartPICC Stylet K240486PM2 System and ECGuide Connector K200037Piccolo Medical SmartPICC System

Dispositivos Relacionados (Código: LJS)

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Fonte oficial

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