DWM · Apparatus, Suction, Patient Care
Cardiovascular · 21 CFR 870.5050 · Class 2
Overview
| Product Code | DWM |
|---|---|
| Device Name | Apparatus, Suction, Patient Care |
| Regulation | 21 CFR 870.5050 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
A patient care suction apparatus is a device used with an intrathoracic catheter to withdraw fluid from the chest during the recovery period following surgery.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (19 of 19)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K212696 | Aspira Pleural Drainage System | Merit Medical Systems, Inc. | Mar 3, 2023 | SESE |
| K210509 | Rocket Platinum Cured Cathter | Rocket Medical Plc | Sep 9, 2021 | SESK |
| K201404 | Passio Pump Drainage System | Bearpac Medical | Nov 20, 2020 | SESE |
| K190292 | Passio Pump Drainage System | Bearpac Medical | Jul 25, 2019 | SESE |
| K163321 | Rocket Indwelling Pleural Catheter (IPC) Insertion Kit | Rocket Medical Plc | Aug 17, 2017 | SESE |
| K160450 | Pleurx Pleural Catheter System | Care Fusion | Oct 31, 2016 | SESE |
| K141965 | PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT | Care Fusion | Jul 2, 2015 | SESE |
| K123033 | ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE B | Rocket Medical Plc | Feb 1, 2013 | SESE |
| K121849 | PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT, PLEURX CATHETER INSERTION STYLET, PLEURX INTEGRAL VALVED PEE | Care Fusion | Oct 18, 2012 | SESE |
| K112831 | PLEURX PLEURAL CATHETER SYSTEMS | Care Fusion | Feb 16, 2012 | SESE |
| K110409 | ASPIRA PLEURAL DRAINAGE SYSTEM | C.R. Bard, Inc. | May 11, 2011 | SESE |
| K093307 | ASEPT PLEURAL DRAINAGE SYSTEM | Pfm Medical, Inc. | Nov 6, 2009 | SESE |
| K071095 | ASPIRA PLEURAL DRAINAGE SYSTEM | Bard Access Systems, Inc. | May 18, 2007 | SESE |
| K052436 | PLEURX PLEURAL CATHETER KIT, MODEL 50-7000 | Denver Biomedical, Inc. | Oct 6, 2005 | SESE |
| K051084 | DENVER PLEURX DRAINAGE KIT AND DENVER PLEURX VACUUM BOTTLE WITH DRAINAGE LINE | Denver Biomedicals, Inc. | Jun 13, 2005 | SESE |
| K011831 | MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS | Denver Biomedical, Inc. | Jun 28, 2001 | SESE |
| K010642 | PLEURX PLEURAL CATHETER AND DRAINAGE KITS | Denver Biomedicals, Inc. | Mar 20, 2001 | SESE |
| K971753 | DENVER PLEURX PLEURAL CATHETER KIT, CATALOG NO. 50-7000, DENVER PLEURX HOME DRAINAGE KIT, CATALOG NO. 50-7500 | Denver Biomaterials, Inc. | Jun 27, 1997 | SESK |
| K803037 | WILLIAM HARVEY VENTED MEDIASTINAL DRAIN | C.R. Bard, Inc. | Feb 4, 1981 | SESE |
Top Applicants
- Care Fusion — 4 clearances
- Rocket Medical Plc — 3 clearances
- Bearpac Medical — 2 clearances
- C.R. Bard, Inc. — 2 clearances
- Denver Biomedical, Inc. — 2 clearances
