FDA 510(k)

PM2™ System with ECGuide™ Connector

N.º K: K252792 · 2025-11-17

Fecha de decisión2025-11-17

Código de productoLJS

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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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Otros registros que enlistan a Piccolo Medical, Inc. como solicitante

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

Dispositivos relacionados (Código: LJS)

K260929Neonav ECG Tip Location SystemNavi Medical Technologies K252373BioFlo 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 Vascular 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.K243484PM2+ System and SmartPICC StyletPiccolo Medical, Inc.K241587pilot TLSVygon Corporation

Fuente oficial

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