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FDA 510(k)

Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit

K-Number: K162457 · 2016-11-14

ApplicantRocket Medical Plc
Decision Date2016-11-14
Product CodePNG
Advisory CommitteeGU
DecisionUnknown

Device Summary

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.

Frequently Asked Questions

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT04322136AMPLE-3: IPC Plus Talc vs VATS in Management of Malignant Pleural EffusionCOMPLETED

Other records listing Rocket Medical Plc as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K210509Rocket Platinum Cured CathterK163321Rocket Indwelling Pleural Catheter (IPC) Insertion KitK152105Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set

Related Devices (Code: PNG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241278ASEPT® Glide Peritoneal Drainage SystemPfm 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 MedicalK221779ASEPT Peritoneal Drainage SystemPfm Medical, Inc.K212675Aspira Peritoneal Drainage SystemMerit Medical Systems, Inc.K201155PleurX Peritoneal Catheter SystemCare Fusion

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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