FDA 510(k)

5 FR Dual Lumen Piper PICC

N.º K: K181904 · 2018-09-25

Fecha de decisión2018-09-25

Código de productoLJS

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

5 FR Dual Lumen Piper PICC is the device name listed in this FDA 510(k) record. The listed applicant is Piper Access, LLC. It received FDA 510(k) clearance on 2018-09-25 under 510(k) number K181904. 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 5 FR Dual Lumen Piper PICC?

5 FR Dual Lumen Piper PICC is a medical device that received FDA 510(k) clearance on 2018-09-25. The listed applicant is Piper Access, LLC. The 510(k) number is K181904.

When did 5 FR Dual Lumen Piper PICC receive FDA 510(k) clearance?

5 FR Dual Lumen Piper PICC received FDA 510(k) clearance on 2018-09-25, under 510(k) number K181904.

Who is the listed applicant for 5 FR Dual Lumen Piper PICC?

The FDA 510(k) record lists Piper Access, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 5 FR Dual Lumen Piper PICC?

The FDA product code for 5 FR Dual Lumen Piper PICC is LJS.

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Otros registros que enlistan a Piper Access, LLC como solicitante

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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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