FDA 510(k)

Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit

Número K: K162457 · 2016-11-14

Data da decisão2016-11-14

Código do produtoPNG

Comité consultivoGU

DecisãoUnknown

Resumo do dispositivo

Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit is the device name listed in this FDA 510(k) record. The listed applicant is Rocket Medical Plc. It received FDA 510(k) clearance on 2016-11-14 under 510(k) number K162457. The device is classified under product code PNG. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Perguntas frequentes

What is the Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit?

Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit is a medical device that received FDA 510(k) clearance on 2016-11-14. The listed applicant is Rocket Medical Plc. The 510(k) number is K162457.

When did Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit receive FDA 510(k) clearance?

Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit received FDA 510(k) clearance on 2016-11-14, under 510(k) number K162457.

Who is the listed applicant for Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit?

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

What is the FDA product code for Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit?

The FDA product code for Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit is PNG.

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Outros registros que listam Rocket Medical Plc como candidato(a)

K210509Rocket Platinum Cured Cathter K163321Rocket Indwelling Pleural Catheter (IPC) Insertion Kit K152105Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set

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.K212675Aspira Peritoneal Drainage SystemMerit Medical Systems, Inc.K201155PleurX Peritoneal Catheter SystemCare Fusion

Fonte oficial

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