DWM — Apparatus, Suction, Patient Care Class II

FDA Device Classification

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-NumberApplicantDevice NameDate
K212696merit medical systemsAspira Pleural Drainage SystemMarch 3, 2023
K210509rocket medicalRocket Platinum Cured CathterSeptember 9, 2021
K201404bearpac medicalPassio Pump Drainage SystemNovember 20, 2020
K190292bearpac medicalPassio Pump Drainage SystemJuly 25, 2019
K163321rocket medicalRocket Indwelling Pleural Catheter (IPC) Insertion KitAugust 17, 2017
K160450care fusionPleurx Pleural Catheter SystemOctober 31, 2016
K141965care fusionPLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KITJuly 2, 2015
K123033rocket medicalROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PAFebruary 1, 2013
K121849care fusionPLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT, PLEURX CATHETER INSEOctober 18, 2012
K112831care fusionPLEURX PLEURAL CATHETER SYSTEMSFebruary 16, 2012
K110409c.r. bardASPIRA PLEURAL DRAINAGE SYSTEMMay 11, 2011
K093307pfm medicalASEPT PLEURAL DRAINAGE SYSTEMNovember 6, 2009
K071095bard access systemsASPIRA PLEURAL DRAINAGE SYSTEMMay 18, 2007
K052436denver biomedicalPLEURX PLEURAL CATHETER KIT, MODEL 50-7000October 6, 2005
K051084denver biomedicalsDENVER PLEURX DRAINAGE KIT AND DENVER PLEURX VACUUM BOTTLE WITH DRAINAGE LINEJune 13, 2005
K011831denver biomedicalMODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITSJune 28, 2001
K010642denver biomedicalsPLEURX PLEURAL CATHETER AND DRAINAGE KITSMarch 20, 2001
K971753denver biomaterialsDENVER PLEURX PLEURAL CATHETER KIT, CATALOG NO. 50-7000, DENVER PLEURX HOME DRAIJune 27, 1997
K803037c.r. bardWILLIAM HARVEY VENTED MEDIASTINAL DRAINFebruary 4, 1981