FDA 510(k)

Sistema de Drenagem Peritoneal ASEPT

Número K: K221779 · 2023-05-02

Data da decisão2023-05-02

Código do produtoPNG

Comité consultivoGU

DecisãoUnknown

Resumo do dispositivo

ASEPT 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 2023-05-02 under 510(k) number K221779. The device is classified under product code PNG. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Perguntas frequentes

What is the ASEPT Peritoneal Drainage System?

ASEPT Peritoneal Drainage System is a medical device that received FDA 510(k) clearance on 2023-05-02. The listed applicant is Pfm Medical, Inc.. The 510(k) number is K221779.

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

ASEPT Peritoneal Drainage System received FDA 510(k) clearance on 2023-05-02, under 510(k) number K221779.

Who is the listed applicant for ASEPT 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 Peritoneal Drainage System?

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

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Outros registros que listam Pfm Medical, Inc. como candidato(a)

K242763JetCan® Pro Safety Huber Needle K241278Sistema de Drenagem Peritoneal ASEPT® Glide K213666NuCath Wedge Pressure Catheter K201137Asept Surgical Face Mask K192802primeMidline Catheters K173114primeMidline Catheters

Ver todos os 7 dispositivos →

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 K212675Aspira Peritoneal Drainage SystemMerit Medical Systems, Inc.K201155PleurX Peritoneal Catheter SystemCare Fusion K162457Rocket Indwelling Peritoneal Catheter (IPC) Insertion KitRocket Medical Plc

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.