Pleurx Pleural Catheter Kit, Model 50-7000
FDA 510(k) K052436 · Denver Biomedical, Inc.
510(k) numberK052436
Submission
- Device name
- Pleurx Pleural Catheter Kit, Model 50-7000
- Applicant
- Denver Biomedical, Inc.
Golden, CO, US - Received
- September 6, 2005
- Decision date
- October 6, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
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|---|---|---|---|
| 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 |
| K112831 | Pleurx Pleural Catheter SystemsDWM · Traditional | Care Fusion | 02/16/2012SE |
More from Care Fusion
| 510(k) | Device | Decision |
|---|---|---|
| K051711 | Pleurx Peritoneal Catheter Kit and Pleurx Drainage KitsPNG · Traditional | 11/15/2005SE |
| K012235 | Denver Pleural Effusion Shunt and Denver Pleural Effusion Shunt with External Pump ChamberKPM · Special | 10/04/2001SE |
| K011862 | Denver Ascites Shunt and Percutaneous Access Kit with Ascities ShuntKPM · Special | 07/12/2001SE |
| K011831 | Modification to Pleurx Pleural Catheter and Drainage KitsDWM · Special | 06/28/2001SE |
Questions and answers
When was Pleurx Pleural Catheter Kit, Model 50-7000 cleared by the FDA?
Pleurx Pleural Catheter Kit, Model 50-7000 (K052436) received a 510(k) decision of Substantially Equivalent on October 6, 2005, 30 days after the submission was received.
What is the product code of K052436?
The FDA product code is DWM – Apparatus, Suction, Patient Care, a Class II (moderate risk) device regulated under 21 CFR 870.5050.