FDA 510(k)

PleurX Peritoneal Catheter System

N.º K: K201155 · 2020-10-21

Fecha de decisión2020-10-21

Código de productoPNG

Comité asesorGU

DecisiónUnknown

Resumen del dispositivo

PleurX Peritoneal Catheter System is the device name listed in this FDA 510(k) record. The listed applicant is Care Fusion. It received FDA 510(k) clearance on 2020-10-21 under 510(k) number K201155. The device is classified under product code PNG. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Preguntas frecuentes

What is the PleurX Peritoneal Catheter System?

PleurX Peritoneal Catheter System is a medical device that received FDA 510(k) clearance on 2020-10-21. The listed applicant is Care Fusion. The 510(k) number is K201155.

When did PleurX Peritoneal Catheter System receive FDA 510(k) clearance?

PleurX Peritoneal Catheter System received FDA 510(k) clearance on 2020-10-21, under 510(k) number K201155.

Who is the listed applicant for PleurX Peritoneal Catheter System?

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

What is the FDA product code for PleurX Peritoneal Catheter System?

The FDA product code for PleurX Peritoneal Catheter System is PNG.

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Dispositivos relacionados (Código: PNG)

K241278Sistema de Drenaje Peritoneal ASEPT® GlidePfm Medical, Inc.K241946PeritX™ 1L Drainage Kit (90-1010); PeritX™ 2L Drainage Kit (90-2010); PeritX™ Peritoneal Catheter Kit (50-9000C); PeritX™ Peritoneal Catheter and Starter Kit (50-9900C); PeritX™ Peritoneal Catheter Mini Kit (50-9050A); PleurX™ Low Profile Catheter Mini Kit (50-8050); Valve Cap (50-7235A); PeritX™ Valve Kit (50-7272); Catheter Access Kit (50-7280A); Lockable Drainage Line (50-7245A); Lockable Drainage Line Kit (50-7265A); PleurX™ Supplemental Insertion Kit (50-7262); Procedure Pack (50-Bard Peripheral Vascular, Inc.K230319Passio Pump Drainage SystemBearpac Medical K221779Sistema de Drenaje Peritoneal ASEPTPfm Medical, Inc.K212675Aspira Peritoneal Drainage SystemMerit Medical Systems, Inc.K162457Rocket Indwelling Peritoneal Catheter (IPC) Insertion KitRocket Medical Plc

Fuente oficial

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