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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