FDA 510(k) Applications for Medical Device Product Code "DWM"
(Apparatus, Suction, Patient Care)

FDA 510(k) Number Applicant Device Name Decision Date
K071095 BARD ACCESS SYSTEMS, INC. ASPIRA PLEURAL DRAINAGE SYSTEM 05/18/2007
K110409 C.R. BARD, INC. ASPIRA PLEURAL DRAINAGE SYSTEM 05/11/2011
K803037 C.R. BARD, INC. WILLIAM HARVEY VENTED MEDIASTINAL DRAIN 02/04/1981
K160450 CAREFUSION Pleurx Pleural Catheter System 10/31/2016
K141965 CAREFUSION PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT 07/02/2015
K121849 CAREFUSION PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT, PLEURX CATHETER INSERTION STYLET, PLEURX INTEGRAL VALVED PEE 10/18/2012
K112831 CAREFUSION PLEURX PLEURAL CATHETER SYSTEMS 02/16/2012
K971753 DENVER BIOMATERIALS, INC. DENVER PLEURX PLEURAL CATHETER KIT, CATALOG NO. 50-7000, DENVER PLEURX HOME DRAINAGE KIT, CATALOG NO. 50-7500 06/27/1997
K011831 DENVER BIOMEDICAL, INC. MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS 06/28/2001
K052436 DENVER BIOMEDICAL, INC. PLEURX PLEURAL CATHETER KIT, MODEL 50-7000 10/06/2005
K051084 DENVER BIOMEDICALS, INC. DENVER PLEURX DRAINAGE KIT AND DENVER PLEURX VACUUM BOTTLE WITH DRAINAGE LINE 06/13/2005
K010642 DENVER BIOMEDICALS, INC. PLEURX PLEURAL CATHETER AND DRAINAGE KITS 03/20/2001
K093307 PFM MEDICAL, INC ASEPT PLEURAL DRAINAGE SYSTEM 11/06/2009
K163321 ROCKET MEDICAL PLC Rocket Indwelling Pleural Catheter (IPC) Insertion Kit 08/17/2017
K123033 ROCKET MEDICAL PLC ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE B 02/01/2013


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