FDA Product Code
FDA Product Code PNG — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5630
510(k) Clearances — 15 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K241278 | ASEPT® Glide Peritoneal Drainage System | Pfm Medical, Inc. | 2025-01-14 | Traditional | PDF ↗ |
| 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 Profile Catheter Mini Kit (50-8050); Valve Cap (50-7235A); PeritX Valve Kit (50-7272); Catheter Access Kit (50-7280A); Lockable Drainage Line (50-7245A); Lockable Drainage Line Kit (50-7265A); PleurX Supplemental Insertion Kit (50-7262); Procedure Pack (50- | Bard Peripheral Vascular, Inc. | 2024-12-06 | Traditional | PDF ↗ |
| K230319 | Passio Pump Drainage System | Bearpac Medical | 2023-11-24 | Traditional | PDF ↗ |
| K221779 | ASEPT Peritoneal Drainage System | Pfm Medical, Inc. | 2023-05-02 | Traditional | PDF ↗ |
| K212675 | Aspira Peritoneal Drainage System | Merit Medical Systems, Inc. | 2021-12-14 | Special | PDF ↗ |
| K201155 | PleurX Peritoneal Catheter System | Care Fusion | 2020-10-21 | Traditional | PDF ↗ |
| K162457 | Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit | Rocket Medical Plc | 2016-11-14 | Traditional | PDF ↗ |
| K160437 | PleurX Peritoneal Catheter System | Care Fusion | 2016-11-03 | Traditional | PDF ↗ |
| K152105 | Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set | Rocket Medical Plc | 2016-03-29 | Traditional | PDF ↗ |
| K122422 | PLEURX PLEURAL CATHETER SYSTEM PLEURX CATHETER ACCESS KIT PLEURX SLIDE VALVED PEELABLE INTRODUCER | Care Fusion | 2012-10-24 | Traditional | PDF ↗ |
| K113854 | PLEURX PERITONEAL CATHETER SYSTEM | Care Fusion | 2012-03-19 | Traditional | PDF ↗ |
| K110396 | ASPIRA PERITONEAL DRAINAGE SYSTEM | C.R. Bard, Inc. | 2011-05-06 | Special | PDF ↗ |
| K093796 | ASEPT PERITONEAL DRAINAGE SYSTEM | Pfm Medical, Inc. | 2010-02-26 | Traditional | PDF ↗ |
| K081288 | ASPIRA PERITONEAL DRAINAGE SYSTEM | C.R. Bard, Inc. | 2008-07-18 | Traditional | PDF ↗ |
| K051711 | PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS | Denver Biomedical, Inc. | 2005-11-15 | Traditional | PDF ↗ |
Product code PNG · Class II · Gastroenterology, Urology. Data: openFDA.