Rocket Platinum Cured Cathter

FDA 510(k) K210509 · Rocket Medical Plc

Unknown

510(k) numberK210509

Submission

Device name
Rocket Platinum Cured Cathter
Applicant
Rocket Medical Plc
Washington, GB
Received
February 22, 2021
Decision date
September 9, 2021
Decision
Unknown (SESK)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DWM – Apparatus, Suction, Patient Care
Device class
Class II (moderate risk)
Regulation
21 CFR 870.5050
Specialty
Cardiovascular

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K190292Passio Pump Drainage SystemDWM · Traditional Bearpac Medical07/25/2019SE
K163321Rocket Indwelling Pleural Catheter (IPC) Insertion KitDWM · Traditional Rocket Medical Plc08/17/2017SE
K160450Pleurx Pleural Catheter SystemDWM · Traditional Care Fusion10/31/2016SE
K141965Pleurx Pleural Catheter System, Pleurx Catheter Access KitDWM · Traditional Care Fusion07/02/2015SE
K123033Rocket Ipc Insertion Pack, Rocket Ipc Mini Insertion Set, Rocket Ipc Dressing Pack and…DWM · Traditional Rocket Medical Plc02/01/2013SE
K121849Pleurx Pleural Catheter System, Pleurx Catheter Access Kit, Pleurx Catheter Insertion…DWM · Traditional Care Fusion10/18/2012SE
K112831Pleurx Pleural Catheter SystemsDWM · Traditional Care Fusion02/16/2012SE
K110409Aspira Pleural Drainage SystemDWM · Special C.R. Bard, Inc.05/11/2011SE

More from C.R. Bard, Inc.

510(k)DeviceDecision
K163321Rocket Indwelling Pleural Catheter (IPC) Insertion KitDWM · Traditional 08/17/2017SE
K162457Rocket Indwelling Peritoneal Catheter (IPC) Insertion KitPNG · Traditional 11/14/2016SEKD
K152105Rocket IPC Insertion Set, Rocket IPC Mini Insertion SetPNG · Traditional 03/29/2016SESK
K123033Rocket Ipc Insertion Pack, Rocket Ipc Mini Insertion Set, Rocket Ipc Dressing Pack and…DWM · Traditional 02/01/2013SE
K052365Cervineedle Disposable Cartridge SyringeHEE · Traditional 10/17/2005SE
K042264GuidewiresDQX · Traditional 11/24/2004SE
K040189Endometrial Sampling SyringeHHK · Traditional 10/04/2004SE
K032015Embryon Ultrasound Needle GuideMQE · Traditional 08/08/2003SE
K000340Hystalog HSG CatheterHES · Traditional 04/19/2000SE
K000205Embryon Single and Double Lumen NeedlesMQE · Traditional 04/19/2000SE

Questions and answers

When was Rocket Platinum Cured Cathter cleared by the FDA?

Rocket Platinum Cured Cathter (K210509) received a 510(k) decision of Unknown on September 9, 2021, 199 days after the submission was received.

What is the product code of K210509?

The FDA product code is DWM – Apparatus, Suction, Patient Care, a Class II (moderate risk) device regulated under 21 CFR 870.5050.