FDA.reportPublic FDA data

510(k) K241278

Device
ASEPT® Glide Peritoneal Drainage System
Applicant
Pfm Medical, Inc.
510(k) number
K241278
Product code
PNG
Decision
Substantially Equivalent (SESE)
Decision date
2025-01-14
Date received
2024-05-06
Regulation
876.5630
Classification name
Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Madison Reid
Address
1916 Palomar Oaks Way Suite 150 Carlsbad CA US 92008 92008

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PNG#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K241946PeritX™ 1L Drainage Kit (90-1010); PeritX™ 2L Drainage Kit (90-2010); PeritX™ Peritoneal Catheter Kit (50-9000C); PeritX™ Peritoneal Catheter and Starter Kit (50-9900C); PeritX™ Peritoneal Catheter Mini Kit (50-9050A); PleurX™ Low Profile Catheter Mini Kit (50-8050); Valve Cap (50-7235A); PeritX™ Valve Kit (50-7272); Catheter Access Kit (50-7280A); Lockable Drainage Line (50-7245A); Lockable Drainage Line Kit (50-7265A); PleurX™ Supplemental Insertion Kit (50-7262); Procedure Pack (50-Bard Peripheral Vascular, Inc.2024-12-06
K230319Passio Pump Drainage SystemBearpac Medical2023-11-24
K221779ASEPT Peritoneal Drainage SystemPfm Medical, Inc.2023-05-02
K212675Aspira Peritoneal Drainage SystemMerit Medical Systems, Inc.2021-12-14
K201155PleurX Peritoneal Catheter SystemCare Fusion2020-10-21
K162457Rocket Indwelling Peritoneal Catheter (IPC) Insertion KitRocket Medical Plc2016-11-14
K160437PleurX Peritoneal Catheter SystemCare Fusion2016-11-03
K152105Rocket IPC Insertion Set, Rocket IPC Mini Insertion SetRocket Medical Plc2016-03-29
K122422PLEURX PLEURAL CATHETER SYSTEM PLEURX CATHETER ACCESS KIT PLEURX SLIDE VALVED PEELABLE INTRODUCERCare Fusion2012-10-24
K113854PLEURX PERITONEAL CATHETER SYSTEMCare Fusion2012-03-19
K110396ASPIRA PERITONEAL DRAINAGE SYSTEMC.R. Bard, Inc.2011-05-06
K093796ASEPT PERITONEAL DRAINAGE SYSTEMPfm Medical, Inc.2010-02-26
K081288ASPIRA PERITONEAL DRAINAGE SYSTEMC.R. Bard, Inc.2008-07-18
K051711PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITSDenver Biomedical, Inc.2005-11-15