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FDA 510(k)

PICC Maximal Barrier Nursing Kit

N.º K: K163452 · 2017-02-03

SolicitanteNavilyst Medical, Inc.
Fecha de decisión2017-02-03
Código de productoLJS
Comité asesorHO
DecisiónUnknown

Resumen del dispositivo

PICC Maximal Barrier Nursing Kit is the device name listed in this FDA 510(k) record. The listed applicant is Navilyst Medical, Inc.. It received FDA 510(k) clearance on 2017-02-03 under 510(k) number K163452. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Unknown.

Preguntas frecuentes

What is the PICC Maximal Barrier Nursing Kit?

PICC Maximal Barrier Nursing Kit is a medical device that received FDA 510(k) clearance on 2017-02-03. The listed applicant is Navilyst Medical, Inc.. The 510(k) number is K163452.

When did PICC Maximal Barrier Nursing Kit receive FDA 510(k) clearance?

PICC Maximal Barrier Nursing Kit received FDA 510(k) clearance on 2017-02-03, under 510(k) number K163452.

Who is the listed applicant for PICC Maximal Barrier Nursing Kit?

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

What is the FDA product code for PICC Maximal Barrier Nursing Kit?

The FDA product code for PICC Maximal Barrier Nursing Kit 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 Navilyst 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.

K161866BioFlo Midline CatheterK151239NMI DUAL PORT II

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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