FDA 510(k)

Rocket Platinum Cured Cathter

K-Number: K210509 · 2021-09-09

Decision Date2021-09-09

Product CodeDWM

Advisory CommitteeCV

DecisionUnknown

Device Summary

Rocket Platinum Cured Cathter is a medical device manufactured by Rocket Medical Plc. It received FDA 510(k) clearance on 2021-09-09 under approval number K210509. The device is classified under product code DWM. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the Rocket Platinum Cured Cathter?

Rocket Platinum Cured Cathter is a medical device that received FDA 510(k) clearance on 2021-09-09. It is manufactured by Rocket Medical Plc. The 510(k) number is K210509.

When was Rocket Platinum Cured Cathter approved by the FDA?

Rocket Platinum Cured Cathter received FDA 510(k) clearance on 2021-09-09, under approval number K210509.

What company makes Rocket Platinum Cured Cathter?

Rocket Platinum Cured Cathter is manufactured by Rocket Medical Plc.

What is the FDA product code for Rocket Platinum Cured Cathter?

The FDA product code for Rocket Platinum Cured Cathter is DWM.

Other Devices by Rocket Medical Plc

K162457Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit K152105Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set K163321Rocket Indwelling Pleural Catheter (IPC) Insertion Kit

Related Devices (Code: DWM)

K160450Pleurx Pleural Catheter SystemCare Fusion K163321Rocket Indwelling Pleural Catheter (IPC) Insertion KitRocket Medical Plc K190292Passio Pump Drainage SystemBearpac Medical K201404Passio Pump Drainage SystemBearpac Medical K212696Aspira Pleural Drainage SystemMerit Medical Systems, Inc.

Official Source

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