Product code PNG
- Device name
- Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5630
- Review panel
- GU
- Implant
- Y
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- For drainage of refractory ascites with long-term occurrence from the peritoneal cavity.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241278 | ASEPT® Glide Peritoneal Drainage System | Pfm Medical, Inc. | 2025-01-14 |
| K241946 | PeritX™ 1L Drainage Kit (90-1010); PeritX™ 2L Drainage Kit (90-2010); PeritX™ Peritoneal Catheter Kit (50-9000C); PeritX™ Peritoneal Catheter and Starter Kit (50-9900C); PeritX™ Peritoneal Catheter Mini Kit (50-9050A); PleurX™ Low Profil... | Bard Peripheral Vascular, Inc. | 2024-12-06 |
| K230319 | Passio Pump Drainage System | Bearpac Medical | 2023-11-24 |
| K221779 | ASEPT Peritoneal Drainage System | Pfm Medical, Inc. | 2023-05-02 |
| K212675 | Aspira Peritoneal Drainage System | Merit Medical Systems, Inc. | 2021-12-14 |
| K201155 | PleurX Peritoneal Catheter System | Care Fusion | 2020-10-21 |
| K162457 | Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit | Rocket Medical Plc | 2016-11-14 |
| K160437 | PleurX Peritoneal Catheter System | Care Fusion | 2016-11-03 |
| K152105 | Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set | Rocket Medical Plc | 2016-03-29 |
| K122422 | PLEURX PLEURAL CATHETER SYSTEM PLEURX CATHETER ACCESS KIT PLEURX SLIDE VALVED PEELABLE INTRODUCER | Care Fusion | 2012-10-24 |
| K113854 | PLEURX PERITONEAL CATHETER SYSTEM | Care Fusion | 2012-03-19 |
| K110396 | ASPIRA PERITONEAL DRAINAGE SYSTEM | C.R. Bard, Inc. | 2011-05-06 |
| K093796 | ASEPT PERITONEAL DRAINAGE SYSTEM | Pfm Medical, Inc. | 2010-02-26 |
| K081288 | ASPIRA PERITONEAL DRAINAGE SYSTEM | C.R. Bard, Inc. | 2008-07-18 |
| K051711 | PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS | Denver Biomedical, Inc. | 2005-11-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00860009032200 | Passio Redressing Kit | Bearpac Medical, LLC | 2025-08-08 |
| 00801741230639 | PeritX | Bard Peripheral Vascular, Inc. | 2025-01-23 |
| 00801741230615 | PeritX | Bard Peripheral Vascular, Inc. | 2025-01-23 |
| 00801741230608 | PeritX | Bard Peripheral Vascular, Inc. | 2025-01-23 |
| 00086000903220 | Passio Redressing Kit | Bearpac Medical, LLC | 2024-02-29 |
| 00860099001322 | Passio Pump Drainage System | Bearpac Medical, LLC | 2023-08-11 |
| 10885403502415 | N/A | CAREFUSION 2200, INC | 2021-03-09 |
| 10885403502408 | N/A | CAREFUSION 2200, INC | 2021-03-09 |
| 10885403502392 | N/A | CAREFUSION 2200, INC | 2021-03-09 |
| 10885403502385 | N/A | CAREFUSION 2200, INC | 2021-03-09 |
| 10885403502378 | N/A | CAREFUSION 2200, INC | 2021-03-09 |
| 10885403502040 | PeritX | CAREFUSION 2200, INC | 2021-03-09 |
| 10885403500831 | PeritX | CAREFUSION 2200, INC | 2021-03-09 |
| 10885403500848 | PeritX | CAREFUSION 2200, INC | 2021-03-09 |
| 00884450394878 | Aspira® | Merit Medical Systems, Inc. | 2019-11-25 |
| 00813623017047 | ASEPT | PFM MEDICAL INCORPORATED | 2019-03-31 |
| 10885403420528 | PleurX | CAREFUSION 2200, INC | 2017-09-25 |
| 10885403075957 | PleurX | CAREFUSION 2200, INC | 2017-09-15 |
| 10885403229435 | PleurX | CAREFUSION 2200, INC | 2017-07-05 |
| 10885403273773 | PleurX | CAREFUSION 2200, INC | 2017-06-12 |
| 10885403193545 | PleurX | CAREFUSION 2200, INC | 2017-06-12 |
| 10885403193026 | PleurX | CAREFUSION 2200, INC | 2017-06-12 |
| 10885403185694 | PleurX | CAREFUSION 2200, INC | 2017-06-12 |
| 10885403185199 | PleurX | CAREFUSION 2200, INC | 2017-06-12 |
| 10885403174872 | PleurX | CAREFUSION 2200, INC | 2017-06-12 |
| 10885403090714 | PleurX | CAREFUSION 2200, INC | 2017-06-12 |
| 10885403090707 | PleurX | CAREFUSION 2200, INC | 2017-06-12 |
| 10885403090684 | PleurX | CAREFUSION 2200, INC | 2017-06-12 |
| 10885403090660 | PleurX | CAREFUSION 2200, INC | 2017-06-12 |
| 00813623017061 | ASEPT Peritoneal Drainage System | PFM MEDICAL INCORPORATED | 2015-10-15 |