Pleurx Pleural Catheter Systems
FDA 510(k) K112831 · Care Fusion
510(k) numberK112831
Submission
- Device name
- Pleurx Pleural Catheter Systems
- Applicant
- Care Fusion
Waukegan, IL, US - Received
- September 28, 2011
- Decision date
- February 16, 2012
- 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 |
| K123033 | Rocket Ipc Insertion Pack, Rocket Ipc Mini Insertion Set, Rocket Ipc Dressing Pack and…DWM · Traditional | Rocket Medical Plc | 02/01/2013SE |
| K121849 | Pleurx Pleural Catheter System, Pleurx Catheter Access Kit, Pleurx Catheter Insertion…DWM · Traditional | Care Fusion | 10/18/2012SE |
| K110409 | Aspira Pleural Drainage SystemDWM · Special | C.R. Bard, Inc. | 05/11/2011SE |
More from C.R. Bard, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K233021 | BD SmartSite 13mm Vial Access Device; BD SmartSite 20mm Vial Access DeviceLHI · Traditional | 03/06/2024SE |
| K231888 | BD Texium Needle-Free SyringeFMF · Traditional | 09/25/2023SE |
| K221327 | BD Alaris Pump Infusion SetsFPA · Traditional | 07/21/2023SE |
| K221319 | BD Alaris Pump Epidural Infusion SetPWH · Traditional | 07/21/2023SE |
| K223101 | BD Secondary Infusion SetFPA · Traditional | 05/12/2023SE |
| K223088 | BD SmartSite Needle-Free ConnectorFPA · Traditional | 04/07/2023SE |
| K223076 | BD Texium Closed Male LuerONB · Traditional | 03/24/2023SE |
| K201155 | PleurX Peritoneal Catheter SystemPNG · Traditional | 10/21/2020SESK |
| K170405 | BD Curve Ascites ShuntKPM · Traditional | 11/02/2017SESK |
| K171531 | Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow…KNW · Traditional | 09/11/2017SE |
Questions and answers
When was Pleurx Pleural Catheter Systems cleared by the FDA?
Pleurx Pleural Catheter Systems (K112831) received a 510(k) decision of Substantially Equivalent on February 16, 2012, 141 days after the submission was received.
What is the product code of K112831?
The FDA product code is DWM – Apparatus, Suction, Patient Care, a Class II (moderate risk) device regulated under 21 CFR 870.5050.