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FDA 510(k)

Rocket Indwelling Pleural Catheter (IPC) Insertion Kit

K-Number: K163321 · 2017-08-17

ApplicantRocket Medical Plc
Decision Date2017-08-17
Product CodeDWM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Rocket Indwelling Pleural Catheter (IPC) Insertion Kit is a medical device manufactured by Rocket Medical Plc. It received FDA 510(k) clearance on 2017-08-17 under approval number K163321. The device is classified under product code DWM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

Rocket Indwelling Pleural Catheter (IPC) Insertion Kit is a medical device that received FDA 510(k) clearance on 2017-08-17. It is manufactured by Rocket Medical Plc. The 510(k) number is K163321.

When was Rocket Indwelling Pleural Catheter (IPC) Insertion Kit approved by the FDA?

Rocket Indwelling Pleural Catheter (IPC) Insertion Kit received FDA 510(k) clearance on 2017-08-17, under approval number K163321.

What company makes Rocket Indwelling Pleural Catheter (IPC) Insertion Kit?

Rocket Indwelling Pleural Catheter (IPC) Insertion Kit is manufactured by Rocket Medical Plc.

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

The FDA product code for Rocket Indwelling Pleural Catheter (IPC) Insertion Kit is DWM.

Related Clinical Trials

NCT06958731 In-plane Versus Real Time Bi-plane Single-operator Laser-assisted With a Innovative T-shaped Probe for Ultrasound-guided Internal Jugular Vein Catheterization:A Randomized Controlled Trial ENROLLING_BY_INVITATION NCT07580651 Quality and Safety of Real-Time Brachytherapy Treatments: Clinical Implementation of a Multipoint Scintillation Detector for Treatment Monitoring NOT_YET_RECRUITING NCT07179705 Using a Hypotension Prediction Index to Prevent Low Blood Pressure During Dialysis in ICU Patients RECRUITING NCT04322136 AMPLE-3: IPC Plus Talc vs VATS in Management of Malignant Pleural Effusion COMPLETED NCT06455228 Long Peripheral Intravenous Catheter Insertion Site and Catheter-related Complications in Antimicrobial Therapy COMPLETED NCT07510451 The Hypotension Prediction Index Versus Standard Advanced Haemodynamic Monitoring in Patients Undergoing Major Aortic Surgery RECRUITING

Other Devices by Rocket Medical Plc

K162457Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit K152105Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set K210509Rocket Platinum Cured Cathter

Related Devices (Code: DWM)

K160450Pleurx Pleural Catheter SystemCare Fusion K190292Passio Pump Drainage SystemBearpac Medical K201404Passio Pump Drainage SystemBearpac Medical K210509Rocket Platinum Cured CathterRocket Medical Plc K212696Aspira Pleural Drainage SystemMerit Medical Systems, Inc.

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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