DWM — Apparatus, Suction, Patient Care Class II
FDA product code DWM covers "Apparatus, Suction, Patient Care", a Class II medical device regulated under 21 CFR 870.5050. Submissions are reviewed by the Cardiovascular panel. At least 19 recent 510(k) clearances have been granted under this product code.
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 |