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FDA 510(k)

Rocket Platinum Cured Cathter

K-Number: K210509 · 2021-09-09

ApplicantRocket Medical Plc
Decision Date2021-09-09
Product CodeDWM
Advisory CommitteeCV
DecisionUnknown

Device Summary

Rocket Platinum Cured Cathter 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 2021-09-09 under 510(k) 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. The listed applicant is Rocket Medical Plc. The 510(k) number is K210509.

When did Rocket Platinum Cured Cathter receive FDA 510(k) clearance?

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

Who is the listed applicant for Rocket Platinum Cured Cathter?

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 Platinum Cured Cathter?

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

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.

K163321Rocket Indwelling Pleural Catheter (IPC) Insertion KitK162457Rocket Indwelling Peritoneal Catheter (IPC) Insertion KitK152105Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set

Related Devices (Code: DWM)

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.

K212696Aspira Pleural Drainage SystemMerit Medical Systems, Inc.K201404Passio Pump Drainage SystemBearpac MedicalK190292Passio Pump Drainage SystemBearpac MedicalK163321Rocket Indwelling Pleural Catheter (IPC) Insertion KitRocket Medical PlcK160450Pleurx Pleural 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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