FDA 510(k)

Sistema de Drenaje Peritoneal ASEPT® Glide

N.º K: K241278 · 2025-01-14

Fecha de decisión2025-01-14

Código de productoPNG

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

ASEPT® Glide Peritoneal Drainage System is the device name listed in this FDA 510(k) record. The listed applicant is Pfm Medical, Inc.. It received FDA 510(k) clearance on 2025-01-14 under 510(k) number K241278. The device is classified under product code PNG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ASEPT® Glide Peritoneal Drainage System?

ASEPT® Glide Peritoneal Drainage System is a medical device that received FDA 510(k) clearance on 2025-01-14. The listed applicant is Pfm Medical, Inc.. The 510(k) number is K241278.

When did ASEPT® Glide Peritoneal Drainage System receive FDA 510(k) clearance?

ASEPT® Glide Peritoneal Drainage System received FDA 510(k) clearance on 2025-01-14, under 510(k) number K241278.

Who is the listed applicant for ASEPT® Glide Peritoneal Drainage System?

The FDA 510(k) record lists Pfm Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASEPT® Glide Peritoneal Drainage System?

The FDA product code for ASEPT® Glide Peritoneal Drainage System is PNG.

Ensayos clínicos relacionados

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Otros registros que enlistan a Pfm Medical, Inc. como solicitante

K242763JetCan® Pro Safety Huber Needle K221779Sistema de Drenaje Peritoneal ASEPT K213666NuCath Wedge Pressure Catheter K201137Asept Surgical Face Mask K192802primeMidline Catheters K173114primeMidline Catheters

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Dispositivos relacionados (Código: PNG)

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.K201155PleurX Peritoneal Catheter SystemCare Fusion K162457Rocket Indwelling Peritoneal Catheter (IPC) Insertion KitRocket Medical Plc

Fuente oficial

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