Panels › Cardiovascular › Product code DWM · Class 2
Apparatus, Suction, Patient Care
Regulation 870.5050
0510(k)s in 12 months (19 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in DWM
| Company | 510(k)s | Recalls |
|---|---|---|
| Care Fusion | 4 | 0 |
| Pfm Medical, Inc. | 1 | 2 |
| Rocket Medical Plc | 3 | 0 |
| Bearpac Medical | 2 | 0 |
| C.R. Bard, Inc. | 2 | 0 |
| Denver Biomedical, Inc. | 2 | 0 |
| Denver Biomedicals, Inc. | 2 | 0 |
| Bard Access Systems, Inc. | 1 | 0 |
| Denver Biomaterials, Inc. | 1 | 0 |
| Mckesson Medical-Surgical Inc. Corporate Office | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 3, 2023 | K212696 | Aspira Pleural Drainage System Merit Medical Systems, Inc. | DWM |
| Sep 9, 2021 | K210509 | Rocket Platinum Cured Cathter Rocket Medical Plc, GB | DWM |
| Nov 20, 2020 | K201404 | Passio Pump Drainage System Bearpac Medical | DWM |
| Jul 25, 2019 | K190292 | Passio Pump Drainage System Bearpac Medical | DWM |
| Aug 17, 2017 | K163321 | Rocket Indwelling Pleural Catheter (IPC) Insertion Kit Rocket Medical Plc, GB | DWM |
| Oct 31, 2016 | K160450 | Pleurx Pleural Catheter System Care Fusion | DWM |
| Jul 2, 2015 | K141965 | PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT Care Fusion | DWM |
| Feb 1, 2013 | K123033 | ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE B Rocket Medical Plc, GB | DWM |
| Oct 18, 2012 | K121849 | PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT, PLEURX CATHETER INSERTION STYLET, PLEURX INTEGRAL VALVED PEE Care Fusion | DWM |
| Feb 16, 2012 | K112831 | PLEURX PLEURAL CATHETER SYSTEMS Care Fusion | DWM |
| May 11, 2011 | K110409 | ASPIRA PLEURAL DRAINAGE SYSTEM C.R. Bard, Inc. | DWM |
| Nov 6, 2009 | K093307 | ASEPT PLEURAL DRAINAGE SYSTEM Pfm Medical, Inc. | DWM |
| May 18, 2007 | K071095 | ASPIRA PLEURAL DRAINAGE SYSTEM Bard Access Systems, Inc. | DWM |
| Oct 6, 2005 | K052436 | PLEURX PLEURAL CATHETER KIT, MODEL 50-7000 Denver Biomedical, Inc. | DWM |
| Jun 13, 2005 | K051084 | DENVER PLEURX DRAINAGE KIT AND DENVER PLEURX VACUUM BOTTLE WITH DRAINAGE LINE Denver Biomedicals, Inc. | DWM |
| Jun 28, 2001 | K011831 | MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS Denver Biomedical, Inc. | DWM |
| Mar 20, 2001 | K010642 | PLEURX PLEURAL CATHETER AND DRAINAGE KITS Denver Biomedicals, Inc. | DWM |
| Jun 27, 1997 | K971753 | DENVER PLEURX PLEURAL CATHETER KIT, CATALOG NO. 50-7000, DENVER PLEURX HOME DRAINAGE KIT, CATALOG NO. 50-7500 Denver Biomaterials, Inc. | DWM |
| Feb 4, 1981 | K803037 | WILLIAM HARVEY VENTED MEDIASTINAL DRAIN C.R. Bard, Inc. | DWM |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.