Data / Medical devices / Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling
Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling (PNG): 12 FDA-registered makers in 5 countries
12 establishments in 5 countries are registered with the FDA to make Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling (product code PNG, Class 2, 21 CFR 876.5630). 6 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 15 510(k) clearances under this code, the latest on January 14, 2025, and lists 1 recall event (0 Class I). FDA data exported November 3, 2026.
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- Product code
- PNG
- Device class
- 2
- Regulation
- 876.5630
- Medical specialty
- Gastroenterology, Urology
- Implant
- Yes
- Life sustaining or supporting
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| China | 2 |
| Mexico | 2 |
| United Kingdom | 1 |
| Dominican Republic | 1 |
Makers of Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Carefusion 2200, Inc. | Vernon Hills, IL, United States | Complaint file establishment, Specification developer | 3 | December 6, 2024 | 0 | 0 | 0 | api.fda.gov |
| PFM Medical, Inc | Carlsbad, CA, United States | Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer | 2 | May 2, 2023 | 0 | 0 | 0 | api.fda.gov |
| Bard Peripheral Vascular, Inc. | Tempe, AZ, United States | Specification developer | 1 | December 6, 2024 | 0 | 0 | 0 | api.fda.gov |
| Bearpac Medical, LLC | Moultonborough, NH, United States | Manufacturer, Specification developer | 1 | November 24, 2023 | 0 | 0 | 0 | api.fda.gov |
| Merit Medical Systems, Inc. | South Jordan, UT, United States | Specification developer | 1 | December 14, 2021 | 0 | 1 | 0 | api.fda.gov |
| Rocket Medical Plc | WASHINGTON Sunderland, United Kingdom | Manufacturer | 1 | March 29, 2016 | 0 | 0 | 0 | api.fda.gov |
| Alleva Medical (D.G.) Ltd | Dongguan City Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bard Reynosa S.A. De C.V. | REYNOSA Tamaulipas, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carefusion 2200, Inc. | Mannford, OK, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CareFusion D.R. 203 Ltd. | SANTO DOMINGO Distrito Nacional, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Merit Maquiladora Mexico, S. DE R.L. DE C.V. | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Turnxon Precision Co., Ltd | Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 14, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.