Product code DWM
- Device name
- Apparatus, Suction, Patient Care
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.5050
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K212696 | Aspira Pleural Drainage System | Merit Medical Systems, Inc. | 2023-03-03 |
| K210509 | Rocket Platinum Cured Cathter | Rocket Medical Plc | 2021-09-09 |
| K201404 | Passio Pump Drainage System | Bearpac Medical | 2020-11-20 |
| K190292 | Passio Pump Drainage System | Bearpac Medical | 2019-07-25 |
| K163321 | Rocket Indwelling Pleural Catheter (IPC) Insertion Kit | Rocket Medical Plc | 2017-08-17 |
| K160450 | Pleurx Pleural Catheter System | Care Fusion | 2016-10-31 |
| K141965 | PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT | Care Fusion | 2015-07-02 |
| 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 |
| K121849 | PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT, PLEURX CATHETER INSERTION STYLET, PLEURX INTEGRAL VALVED PEE | Care Fusion | 2012-10-18 |
| K112831 | PLEURX PLEURAL CATHETER SYSTEMS | Care Fusion | 2012-02-16 |
| K110409 | ASPIRA PLEURAL DRAINAGE SYSTEM | C.R. Bard, Inc. | 2011-05-11 |
| K093307 | ASEPT PLEURAL DRAINAGE SYSTEM | Pfm Medical, Inc. | 2009-11-06 |
| K071095 | ASPIRA PLEURAL DRAINAGE SYSTEM | Bard Access Systems, Inc. | 2007-05-18 |
| K052436 | PLEURX PLEURAL CATHETER KIT, MODEL 50-7000 | Denver Biomedical, Inc. | 2005-10-06 |
| K051084 | DENVER PLEURX DRAINAGE KIT AND DENVER PLEURX VACUUM BOTTLE WITH DRAINAGE LINE | Denver Biomedicals, Inc. | 2005-06-13 |
| K011831 | MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS | Denver Biomedical, Inc. | 2001-06-28 |
| K010642 | PLEURX PLEURAL CATHETER AND DRAINAGE KITS | Denver Biomedicals, Inc. | 2001-03-20 |
| 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 |
| K803037 | WILLIAM HARVEY VENTED MEDIASTINAL DRAIN | C.R. Bard, Inc. | 1981-02-04 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00860099001391 | Passio Valve Cap Kit | Bearpac Medical, LLC | 2024-02-29 |
| 00860099001346 | Passio Catheter Valve Replacement Kit | Bearpac Medical, LLC | 2023-08-25 |
| 10885403502415 | N/A | CAREFUSION 2200, INC | 2021-03-09 |
| 10885403502408 | N/A | CAREFUSION 2200, INC | 2021-03-09 |
| 10885403502392 | N/A | CAREFUSION 2200, INC | 2021-03-09 |
| 10885403502385 | N/A | CAREFUSION 2200, INC | 2021-03-09 |
| 10885403502378 | N/A | CAREFUSION 2200, INC | 2021-03-09 |
| 00884450394922 | Aspira® | Merit Medical Systems, Inc. | 2020-07-24 |
| 00884450394915 | Aspira® | Merit Medical Systems, Inc. | 2019-12-05 |
| 00884450394861 | Aspira® | Merit Medical Systems, Inc. | 2019-09-23 |
| 00813623017054 | ASEPT | PFM MEDICAL INCORPORATED | 2019-03-31 |
| 10885403420528 | PleurX | CAREFUSION 2200, INC | 2017-09-25 |
| 10885403075971 | PleurX | CAREFUSION 2200, INC | 2017-09-15 |
| 10885403231520 | PleurX | CAREFUSION 2200, INC | 2017-09-15 |
| 10885403229435 | PleurX | CAREFUSION 2200, INC | 2017-07-05 |
| 10885403090684 | PleurX | CAREFUSION 2200, INC | 2017-06-12 |
| 10885403090660 | PleurX | CAREFUSION 2200, INC | 2017-06-12 |
| 10885403185694 | PleurX | CAREFUSION 2200, INC | 2017-06-12 |
| 10885403090707 | PleurX | CAREFUSION 2200, INC | 2017-06-12 |
| 10885403090714 | PleurX | CAREFUSION 2200, INC | 2017-06-12 |
| 10885403174872 | PleurX | CAREFUSION 2200, INC | 2017-06-12 |
| 10885403185199 | PleurX | CAREFUSION 2200, INC | 2017-06-12 |
| 10885403222412 | PeritX | CAREFUSION 2200, INC | 2017-06-12 |
| 10885403193545 | PleurX | CAREFUSION 2200, INC | 2017-06-12 |
| 10885403193026 | PleurX | CAREFUSION 2200, INC | 2017-06-12 |
| 10885403075988 | PleurX | CAREFUSION 2200, INC | 2016-10-07 |
| 00813623011359 | ASEPT Pleural Drainage System | PFM MEDICAL INCORPORATED | 2016-10-02 |
| 00813623017016 | ASEPT Pleural Drainage System | PFM MEDICAL INCORPORATED | 2016-10-02 |
| 00801741045011 | Aspira Dressing Kit | Bard Access Systems, Inc. | 2015-11-20 |
| 00801741045073 | Aspira Drainage Tray | Bard Access Systems, Inc. | 2015-11-20 |