FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K071095 |
BARD ACCESS SYSTEMS, INC. |
ASPIRA PLEURAL DRAINAGE SYSTEM |
05/18/2007 |
K190292 |
Bearpac Medical |
Passio Pump Drainage System |
07/25/2019 |
K201404 |
Bearpac Medical |
Passio Pump Drainage System |
11/20/2020 |
K110409 |
C.R. BARD, INC. |
ASPIRA PLEURAL DRAINAGE SYSTEM |
05/11/2011 |
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 |
K212696 |
Merit Medical Systems, Inc. |
Aspira Pleural Drainage System |
03/03/2023 |
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 |
K210509 |
Rocket Medical Plc |
Rocket Platinum Cured Cathter |
09/09/2021 |