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FDA 510(k)

PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter)

N.º K: K172423 · 2018-02-20

SolicitanteEdwards Lifescience, LLC
Fecha de decisión2018-02-20
Código de productoDQE
Comité asesorCV
DecisiónSubstantially Equivalent

Resumen del dispositivo

PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter) is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifescience, LLC. It received FDA 510(k) clearance on 2018-02-20 under 510(k) number K172423. The device is classified under product code DQE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter)?

PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter) is a medical device that received FDA 510(k) clearance on 2018-02-20. The listed applicant is Edwards Lifescience, LLC. The 510(k) number is K172423.

When did PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter) receive FDA 510(k) clearance?

PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter) received FDA 510(k) clearance on 2018-02-20, under 510(k) number K172423.

Who is the listed applicant for PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter)?

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

What is the FDA product code for PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter)?

The FDA product code for PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter) is DQE.

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.

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Dispositivos relacionados (Código: DQE)

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.

K160645PreSep Oligon Oximetry CatheterEdwards Lifesciences, LLC

Fuente oficial

Ver en la base de datos de la FDA →

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