DWM — Apparatus, Suction, Patient Care Class II
FDA Device Classification
Classification Details
- Product Code
- DWM
- Device Class
- Class II
- Regulation Number
- 870.5050
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
| K212696 | merit medical systems | Aspira Pleural Drainage System | March 3, 2023 |
| K210509 | rocket medical | Rocket Platinum Cured Cathter | September 9, 2021 |
| K201404 | bearpac medical | Passio Pump Drainage System | November 20, 2020 |
| K190292 | bearpac medical | Passio Pump Drainage System | July 25, 2019 |
| K163321 | rocket medical | Rocket Indwelling Pleural Catheter (IPC) Insertion Kit | August 17, 2017 |
| K160450 | care fusion | Pleurx Pleural Catheter System | October 31, 2016 |
| K141965 | care fusion | PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT | July 2, 2015 |
| K123033 | rocket medical | ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PA | February 1, 2013 |
| K121849 | care fusion | PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT, PLEURX CATHETER INSE | October 18, 2012 |
| K112831 | care fusion | PLEURX PLEURAL CATHETER SYSTEMS | February 16, 2012 |
| K110409 | c.r. bard | ASPIRA PLEURAL DRAINAGE SYSTEM | May 11, 2011 |
| K093307 | pfm medical | ASEPT PLEURAL DRAINAGE SYSTEM | November 6, 2009 |
| K071095 | bard access systems | ASPIRA PLEURAL DRAINAGE SYSTEM | May 18, 2007 |
| K052436 | denver biomedical | PLEURX PLEURAL CATHETER KIT, MODEL 50-7000 | October 6, 2005 |
| K051084 | denver biomedicals | DENVER PLEURX DRAINAGE KIT AND DENVER PLEURX VACUUM BOTTLE WITH DRAINAGE LINE | June 13, 2005 |
| K011831 | denver biomedical | MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS | June 28, 2001 |
| K010642 | denver biomedicals | PLEURX PLEURAL CATHETER AND DRAINAGE KITS | March 20, 2001 |
| K971753 | denver biomaterials | DENVER PLEURX PLEURAL CATHETER KIT, CATALOG NO. 50-7000, DENVER PLEURX HOME DRAI | June 27, 1997 |
| K803037 | c.r. bard | WILLIAM HARVEY VENTED MEDIASTINAL DRAIN | February 4, 1981 |