PNG
- 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.
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K241278 | 2025-01-14 | Pfm Medical, Inc. | ASEPT® Glide Peritoneal Drainage System | |
| K241946 | 2024-12-06 | Bard Peripheral Vascular, Inc. | PeritX 1L Drainage Kit (90-1010); PeritX 2L Draina… | |
| K230319 | 2023-11-24 | Bearpac Medical | Passio Pump Drainage System | — |
Official FDA classification page: PNG
Classification and pathway per current FDA publications. Data from openFDA (CC0).