FDA 510(k)

Aspira Peritoneal Drainage System

Número K: K212675 · 2021-12-14

Data da decisão2021-12-14

Código do produtoPNG

Comité consultivoGU

DecisãoUnknown

Resumo do dispositivo

Aspira Peritoneal Drainage System is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2021-12-14 under 510(k) number K212675. The device is classified under product code PNG. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Perguntas frequentes

What is the Aspira Peritoneal Drainage System?

Aspira Peritoneal Drainage System is a medical device that received FDA 510(k) clearance on 2021-12-14. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K212675.

When did Aspira Peritoneal Drainage System receive FDA 510(k) clearance?

Aspira Peritoneal Drainage System received FDA 510(k) clearance on 2021-12-14, under 510(k) number K212675.

Who is the listed applicant for Aspira Peritoneal Drainage System?

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

What is the FDA product code for Aspira Peritoneal Drainage System?

The FDA product code for Aspira Peritoneal Drainage System is PNG.

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Dispositivos Relacionados (Código: PNG)

K241278Sistema de Drenagem 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 Drenagem Peritoneal ASEPTPfm Medical, Inc.K201155PleurX Peritoneal Catheter SystemCare Fusion K162457Rocket Indwelling Peritoneal Catheter (IPC) Insertion KitRocket Medical Plc

Fonte oficial

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