FDA 510(k)

CATHTONG II PICC Catheter

N.º K: K170486 · 2017-05-25

Fecha de decisión2017-05-25

Código de productoLJS

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

CATHTONG II PICC Catheter is the device name listed in this FDA 510(k) record. The listed applicant is L&Z Us, Inc.. It received FDA 510(k) clearance on 2017-05-25 under 510(k) number K170486. 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 CATHTONG II PICC Catheter?

CATHTONG II PICC Catheter is a medical device that received FDA 510(k) clearance on 2017-05-25. The listed applicant is L&Z Us, Inc.. The 510(k) number is K170486.

When did CATHTONG II PICC Catheter receive FDA 510(k) clearance?

CATHTONG II PICC Catheter received FDA 510(k) clearance on 2017-05-25, under 510(k) number K170486.

Who is the listed applicant for CATHTONG II PICC Catheter?

The FDA 510(k) record lists L&Z Us, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CATHTONG II PICC Catheter?

The FDA product code for CATHTONG II PICC Catheter is LJS.

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Otros registros que enlistan a L&Z Us, Inc. como solicitante

K233149CATHTONG III Tapered PICC Catheter K232571CATHTONG™ II PICC Catheter K232594CATHTONG™ II PICC Catheter K172039CATHTONG II PICC Catheter K153469Cathtong I PICC Catheter

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 K252792PM2™ 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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