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FDA 510(k)

Piccolo Medical SmartPICC System

N.º K: K200037 · 2021-01-22

SolicitantePiccolo Medical, Inc.
Fecha de decisión2021-01-22
Código de productoLJS
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

Piccolo Medical SmartPICC System 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 2021-01-22 under 510(k) number K200037. 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 Piccolo Medical SmartPICC System?

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

When did Piccolo Medical SmartPICC System receive FDA 510(k) clearance?

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

Who is the listed applicant for Piccolo Medical SmartPICC System?

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 Piccolo Medical SmartPICC System?

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

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K252792PM2™ System with ECGuide™ ConnectorK243484PM2+ System and SmartPICC StyletK240486PM2 System and ECGuide Connector

Dispositivos relacionados (Código: LJS)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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.K243484PM2+ System and SmartPICC StyletPiccolo Medical, Inc.

Fuente oficial

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