PNG

Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling

Product code
PNG
Device name
Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling
Device class
Class 2
21 CFR
21 CFR 876.5630
Medical specialty
Gastroenterology, Urology
Marketing pathway
510(K)
Flag
Implant
Flag
Life-sustaining / life-supporting
510(k) clearances (last 3 years)
3
Summaries archived here
2 (direct download)
510(k) clearances (all years, FDA)
15 (all years; only the last 3 years are listed here)

FDA classification definition

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

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (3)

Last three years. Most recent: 2025-01-14.

NumberDecision dateApplicantDevice nameSummary
K2412782025-01-14Pfm Medical, Inc.ASEPT® Glide Peritoneal Drainage SystemPDF
K2419462024-12-06Bard Peripheral Vascular, Inc.PeritX™ 1L Drainage Kit (90-1010); PeritX™ 2L Draina…PDF
K2303192023-11-24Bearpac MedicalPassio Pump Drainage System

2 summaries are archived here for direct download.

Official FDA classification page: PNG
Classification and pathway per current FDA publications. Data from openFDA (CC0).