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FDA 510(k) Applications for Medical Device Product Code "PNG"
FDA 510(k) Number
Applicant
Device Name
Decision Date
K081288
C.R. BARD, INC.
ASPIRA PERITONEAL DRAINAGE SYSTEM
07/18/2008
K110396
C.R. BARD, INC.
ASPIRA PERITONEAL DRAINAGE SYSTEM
05/06/2011
K113854
CAREFUSION
PLEURX PERITONEAL CATHETER SYSTEM
03/19/2012
K160437
CareFusion
PleurX Peritoneal Catheter System
11/03/2016
K201155
CareFusion
PleurX Peritoneal Catheter System
10/21/2020
K122422
CAREFUSION
PLEURX PLEURAL CATHETER SYSTEM PLEURX CATHETER ACCESS KIT PLEURX SLIDE VALVED PEELABLE INTRODUCER
10/24/2012
K051711
DENVER BIOMEDICAL, INC.
PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS
11/15/2005
K212675
Merit Medical Systems, Inc.
Aspira Peritoneal Drainage System
12/14/2021
K093796
PFM MEDICAL, INC
ASEPT PERITONEAL DRAINAGE SYSTEM
02/26/2010
K221779
PFM Medical, Inc.
ASEPT Peritoneal Drainage System
05/02/2023
K162457
Rocket Medical Plc
Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit
11/14/2016
K152105
ROCKET MEDICAL PLC
Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set
03/29/2016
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