FDA 510(k)

Biowy PlCC Catheter

N.º K: K173956 · 2018-05-21

Fecha de decisión2018-05-21

Código de productoLJS

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Biowy PlCC Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Biowy Corporation. It received FDA 510(k) clearance on 2018-05-21 under 510(k) number K173956. 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 Biowy PlCC Catheter?

Biowy PlCC Catheter is a medical device that received FDA 510(k) clearance on 2018-05-21. The listed applicant is Biowy Corporation. The 510(k) number is K173956.

When did Biowy PlCC Catheter receive FDA 510(k) clearance?

Biowy PlCC Catheter received FDA 510(k) clearance on 2018-05-21, under 510(k) number K173956.

Who is the listed applicant for Biowy PlCC Catheter?

The FDA 510(k) record lists Biowy Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Biowy PlCC Catheter?

The FDA product code for Biowy PlCC Catheter is LJS.

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Otros registros que enlistan a Biowy Corporation como solicitante

K233658Biowy Tym Tube (TT)K192246Biowy PICC Catheter S Kit

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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