FDA Product Code
FDA Product Code DWM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.5050
510(k) Clearances — 19 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K212696 | Aspira Pleural Drainage System | Merit Medical Systems, Inc. | 2023-03-03 | Traditional | PDF ↗ |
| K210509 | Rocket Platinum Cured Cathter | Rocket Medical Plc | 2021-09-09 | Traditional | PDF ↗ |
| K201404 | Passio Pump Drainage System | Bearpac Medical | 2020-11-20 | Traditional | PDF ↗ |
| K190292 | Passio Pump Drainage System | Bearpac Medical | 2019-07-25 | Traditional | PDF ↗ |
| K163321 | Rocket Indwelling Pleural Catheter (IPC) Insertion Kit | Rocket Medical Plc | 2017-08-17 | Traditional | PDF ↗ |
| K160450 | Pleurx Pleural Catheter System | Care Fusion | 2016-10-31 | Traditional | PDF ↗ |
| K141965 | PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT | Care Fusion | 2015-07-02 | Traditional | PDF ↗ |
| K123033 | ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE B | Rocket Medical Plc | 2013-02-01 | Traditional | PDF ↗ |
| K121849 | PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT, PLEURX CATHETER INSERTION STYLET, PLEURX INTEGRAL VALVED PEE | Care Fusion | 2012-10-18 | Traditional | PDF ↗ |
| K112831 | PLEURX PLEURAL CATHETER SYSTEMS | Care Fusion | 2012-02-16 | Traditional | PDF ↗ |
| K110409 | ASPIRA PLEURAL DRAINAGE SYSTEM | C.R. Bard, Inc. | 2011-05-11 | Special | PDF ↗ |
| K093307 | ASEPT PLEURAL DRAINAGE SYSTEM | Pfm Medical, Inc. | 2009-11-06 | Traditional | PDF ↗ |
| K071095 | ASPIRA PLEURAL DRAINAGE SYSTEM | Bard Access Systems, Inc. | 2007-05-18 | Traditional | PDF ↗ |
| K052436 | PLEURX PLEURAL CATHETER KIT, MODEL 50-7000 | Denver Biomedical, Inc. | 2005-10-06 | Special | PDF ↗ |
| K051084 | DENVER PLEURX DRAINAGE KIT AND DENVER PLEURX VACUUM BOTTLE WITH DRAINAGE LINE | Denver Biomedicals, Inc. | 2005-06-13 | Special | PDF ↗ |
| K011831 | MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS | Denver Biomedical, Inc. | 2001-06-28 | Special | PDF ↗ |
| K010642 | PLEURX PLEURAL CATHETER AND DRAINAGE KITS | Denver Biomedicals, Inc. | 2001-03-20 | Traditional | PDF ↗ |
| K971753 | DENVER PLEURX PLEURAL CATHETER KIT, CATALOG NO. 50-7000, DENVER PLEURX HOME DRAINAGE KIT, CATALOG NO. 50-7500 | Denver Biomaterials, Inc. | 1997-06-27 | Traditional | PDF ↗ |
| K803037 | WILLIAM HARVEY VENTED MEDIASTINAL DRAIN | C.R. Bard, Inc. | 1981-02-04 | Traditional | PDF ↗ |
Product code DWM · Class II · Cardiovascular. Data: openFDA.