Panels › Gastroenterology, Urology › Product code PNG · Class 2
Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling
Regulation 876.5630
0510(k)s in 12 months (15 all time)
0recalls in 12 months (13 all time)
13recalls that name a 510(k)
Top companies in PNG
| Company | 510(k)s | Recalls |
|---|---|---|
| Merit Medical Systems, Inc. | 1 | 13 |
| Care Fusion | 4 | 0 |
| Pfm Medical, Inc. | 3 | 0 |
| C.R. Bard, Inc. | 2 | 0 |
| Rocket Medical Plc | 2 | 0 |
| Bard Peripheral Vascular, Inc. | 1 | 0 |
| Bearpac Medical | 1 | 0 |
| Denver Biomedical, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 14, 2025 | K241278 | ASEPT® Glide Peritoneal Drainage System Pfm Medical, Inc. | PNG |
| Dec 6, 2024 | K241946 | PeritX 1L Drainage Kit (90-1010); PeritX 2L Drainage Kit (90-2010); PeritX Peritoneal Catheter Kit (50-9000C); PeritX Bard Peripheral Vascular, Inc. | PNG |
| Nov 24, 2023 | K230319 | Passio Pump Drainage System Bearpac Medical | PNG |
| May 2, 2023 | K221779 | ASEPT Peritoneal Drainage System Pfm Medical, Inc. | PNG |
| Dec 14, 2021 | K212675 | Aspira Peritoneal Drainage System Merit Medical Systems, Inc. | PNG |
| Oct 21, 2020 | K201155 | PleurX Peritoneal Catheter System Care Fusion | PNG |
| Nov 14, 2016 | K162457 | Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit Rocket Medical Plc, GB | PNG |
| Nov 3, 2016 | K160437 | PleurX Peritoneal Catheter System Care Fusion | PNG |
| Mar 29, 2016 | K152105 | Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set Rocket Medical Plc, GB | PNG |
| Oct 24, 2012 | K122422 | PLEURX PLEURAL CATHETER SYSTEM PLEURX CATHETER ACCESS KIT PLEURX SLIDE VALVED PEELABLE INTRODUCER Care Fusion | PNG |
| Mar 19, 2012 | K113854 | PLEURX PERITONEAL CATHETER SYSTEM Care Fusion | PNG |
| May 6, 2011 | K110396 | ASPIRA PERITONEAL DRAINAGE SYSTEM C.R. Bard, Inc. | PNG |
| Feb 26, 2010 | K093796 | ASEPT PERITONEAL DRAINAGE SYSTEM Pfm Medical, Inc. | PNG |
| Jul 18, 2008 | K081288 | ASPIRA PERITONEAL DRAINAGE SYSTEM C.R. Bard, Inc. | PNG |
| Nov 15, 2005 | K051711 | PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS Denver Biomedical, Inc. | PNG |
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