FDA 510(k) Applications for Medical Device Product Code: PNG ()

FDA 510(k) Applications for Medical Device Product Code "PNG"

FDA 510(k) Number	Applicant	Device Name	Decision Date
K241946	Bard Peripheral Vascular, Inc	PeritXÖ 1L Drainage Kit (90-1010); PeritXÖ 2L Drainage Kit (90-2010); PeritXÖ Peritoneal Catheter Kit (50-9000C); PeritXÖ Peritoneal Catheter and Starter Kit (50-9900C); PeritXÖ Peritoneal Catheter Mini Kit (50-9050A); PleurXÖ Low Profile Catheter Mini Ki	12/06/2024
K230319	Bearpac Medical	Passio Pump Drainage System	11/24/2023
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
K241278	PFM Medical, Inc.	ASEPT« Glide Peritoneal Drainage System	01/14/2025
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