Rocket Ipc Insertion Pack, Rocket Ipc Mini Insertion Set, Rocket Ipc Dressing Pack and Bottle Set, Rocket Ipc Drainage B
FDA 510(k) K123033 · Rocket Medical Plc
510(k) numberK123033
Submission
- Device name
- Rocket Ipc Insertion Pack, Rocket Ipc Mini Insertion Set, Rocket Ipc Dressing Pack and Bottle Set, Rocket Ipc Drainage B
- Applicant
- Rocket Medical Plc
Washington, Tyne & Wear, GB - Received
- September 28, 2012
- Decision date
- February 1, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DWM – Apparatus, Suction, Patient Care
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5050
- Specialty
- Cardiovascular
Other 510(k)s with product code DWM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K212696 | Aspira Pleural Drainage SystemDWM · Traditional | Merit Medical Systems, Inc. | 03/03/2023SE |
| K210509 | Rocket Platinum Cured CathterDWM · Traditional | Rocket Medical Plc | 09/09/2021SESK |
| K201404 | Passio Pump Drainage SystemDWM · Traditional | Bearpac Medical | 11/20/2020SE |
| K190292 | Passio Pump Drainage SystemDWM · Traditional | Bearpac Medical | 07/25/2019SE |
| K163321 | Rocket Indwelling Pleural Catheter (IPC) Insertion KitDWM · Traditional | Rocket Medical Plc | 08/17/2017SE |
| K160450 | Pleurx Pleural Catheter SystemDWM · Traditional | Care Fusion | 10/31/2016SE |
| K141965 | Pleurx Pleural Catheter System, Pleurx Catheter Access KitDWM · Traditional | Care Fusion | 07/02/2015SE |
| K121849 | Pleurx Pleural Catheter System, Pleurx Catheter Access Kit, Pleurx Catheter Insertion…DWM · Traditional | Care Fusion | 10/18/2012SE |
| K112831 | Pleurx Pleural Catheter SystemsDWM · Traditional | Care Fusion | 02/16/2012SE |
| K110409 | Aspira Pleural Drainage SystemDWM · Special | C.R. Bard, Inc. | 05/11/2011SE |
More from C.R. Bard, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K210509 | Rocket Platinum Cured CathterDWM · Traditional | 09/09/2021SESK |
| K163321 | Rocket Indwelling Pleural Catheter (IPC) Insertion KitDWM · Traditional | 08/17/2017SE |
| K162457 | Rocket Indwelling Peritoneal Catheter (IPC) Insertion KitPNG · Traditional | 11/14/2016SEKD |
| K152105 | Rocket IPC Insertion Set, Rocket IPC Mini Insertion SetPNG · Traditional | 03/29/2016SESK |
| K052365 | Cervineedle Disposable Cartridge SyringeHEE · Traditional | 10/17/2005SE |
| K042264 | GuidewiresDQX · Traditional | 11/24/2004SE |
| K040189 | Endometrial Sampling SyringeHHK · Traditional | 10/04/2004SE |
| K032015 | Embryon Ultrasound Needle GuideMQE · Traditional | 08/08/2003SE |
| K000340 | Hystalog HSG CatheterHES · Traditional | 04/19/2000SE |
| K000205 | Embryon Single and Double Lumen NeedlesMQE · Traditional | 04/19/2000SE |
Questions and answers
When was Rocket Ipc Insertion Pack, Rocket Ipc Mini Insertion Set, Rocket Ipc Dressing Pack and Bottle Set, Rocket Ipc Drainage B cleared by the FDA?
Rocket Ipc Insertion Pack, Rocket Ipc Mini Insertion Set, Rocket Ipc Dressing Pack and Bottle Set, Rocket Ipc Drainage B (K123033) received a 510(k) decision of Substantially Equivalent on February 1, 2013, 126 days after the submission was received.
What is the product code of K123033?
The FDA product code is DWM – Apparatus, Suction, Patient Care, a Class II (moderate risk) device regulated under 21 CFR 870.5050.