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PNG — Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling Class II

FDA Device Classification

Classification Details

Product Code
PNG
Device Class
Class II
Regulation Number
876.5630
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
Yes

Definition

For drainage of refractory ascites with long-term occurrence from the peritoneal cavity.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K241278pfm medicalASEPT® Glide Peritoneal Drainage SystemJanuary 14, 2025
K241946bard peripheral vascularPeritX™ 1L Drainage Kit (90-1010); PeritX™ 2L Drainage Kit (90-2010); PeritX™ PeDecember 6, 2024
K230319bearpac medicalPassio Pump Drainage SystemNovember 24, 2023
K221779pfm medicalASEPT Peritoneal Drainage SystemMay 2, 2023
K212675merit medical systemsAspira Peritoneal Drainage SystemDecember 14, 2021
K201155care fusionPleurX Peritoneal Catheter SystemOctober 21, 2020
K162457rocket medicalRocket Indwelling Peritoneal Catheter (IPC) Insertion KitNovember 14, 2016
K160437care fusionPleurX Peritoneal Catheter SystemNovember 3, 2016
K152105rocket medicalRocket IPC Insertion Set, Rocket IPC Mini Insertion SetMarch 29, 2016
K122422care fusionPLEURX PLEURAL CATHETER SYSTEM PLEURX CATHETER ACCESS KIT PLEURX SLIDE VALVED PEOctober 24, 2012
K113854care fusionPLEURX PERITONEAL CATHETER SYSTEMMarch 19, 2012
K110396c.r. bardASPIRA PERITONEAL DRAINAGE SYSTEMMay 6, 2011
K093796pfm medicalASEPT PERITONEAL DRAINAGE SYSTEMFebruary 26, 2010
K081288c.r. bardASPIRA PERITONEAL DRAINAGE SYSTEMJuly 18, 2008
K051711denver biomedicalPLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITSNovember 15, 2005