FDA 510(k)

Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set

N.º K: K152105 · 2016-03-29

Fecha de decisión2016-03-29

Código de productoPNG

Comité asesorGU

DecisiónUnknown

Resumen del dispositivo

Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set 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 2016-03-29 under 510(k) number K152105. The device is classified under product code PNG. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Preguntas frecuentes

What is the Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set?

Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set is a medical device that received FDA 510(k) clearance on 2016-03-29. The listed applicant is Rocket Medical Plc. The 510(k) number is K152105.

When did Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set receive FDA 510(k) clearance?

Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set received FDA 510(k) clearance on 2016-03-29, under 510(k) number K152105.

Who is the listed applicant for Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set?

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 IPC Insertion Set, Rocket IPC Mini Insertion Set?

The FDA product code for Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set is PNG.

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Otros registros que enlistan a Rocket Medical Plc como solicitante

K210509Rocket Platinum Cured Cathter K163321Rocket Indwelling Pleural Catheter (IPC) Insertion Kit K162457Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit

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.K201155PleurX Peritoneal Catheter SystemCare Fusion

Fuente oficial

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