PNG — Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling Class II
FDA product code PNG covers "Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling", a Class II medical device regulated under 21 CFR 876.5630. Submissions are reviewed by the Gastroenterology, Urology panel. Devices under this code are implants. At least 15 recent 510(k) clearances have been granted under this product code.
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-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K241278 | pfm medical | ASEPT® Glide Peritoneal Drainage System | January 14, 2025 |
| K241946 | bard peripheral vascular | PeritX 1L Drainage Kit (90-1010); PeritX 2L Drainage Kit (90-2010); PeritX Pe | December 6, 2024 |
| K230319 | bearpac medical | Passio Pump Drainage System | November 24, 2023 |
| K221779 | pfm medical | ASEPT Peritoneal Drainage System | May 2, 2023 |
| K212675 | merit medical systems | Aspira Peritoneal Drainage System | December 14, 2021 |
| K201155 | care fusion | PleurX Peritoneal Catheter System | October 21, 2020 |
| K162457 | rocket medical | Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit | November 14, 2016 |
| K160437 | care fusion | PleurX Peritoneal Catheter System | November 3, 2016 |
| K152105 | rocket medical | Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set | March 29, 2016 |
| K122422 | care fusion | PLEURX PLEURAL CATHETER SYSTEM PLEURX CATHETER ACCESS KIT PLEURX SLIDE VALVED PE | October 24, 2012 |
| K113854 | care fusion | PLEURX PERITONEAL CATHETER SYSTEM | March 19, 2012 |
| K110396 | c.r. bard | ASPIRA PERITONEAL DRAINAGE SYSTEM | May 6, 2011 |
| K093796 | pfm medical | ASEPT PERITONEAL DRAINAGE SYSTEM | February 26, 2010 |
| K081288 | c.r. bard | ASPIRA PERITONEAL DRAINAGE SYSTEM | July 18, 2008 |
| K051711 | denver biomedical | PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS | November 15, 2005 |