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 Drain
FDA 510(k) K241946 · Bard Peripheral Vascular, Inc.
510(k) numberK241946
Submission
- Device name
- 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 Drain
- Applicant
- Bard Peripheral Vascular, Inc.
Tempe, AZ, US - Received
- July 3, 2024
- Decision date
- December 6, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PNG – Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5630
- Specialty
- Gastroenterology, Urology
- Implant
- Yes
- Life-sustaining
- Yes
For drainage of refractory ascites with long-term occurrence from the peritoneal cavity.
Other 510(k)s with product code PNG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241278 | ASEPT® Glide Peritoneal Drainage SystemPNG · Traditional | Pfm Medical, Inc. | 01/14/2025SE |
| K230319 | Passio Pump Drainage SystemPNG · Traditional | Bearpac Medical | 11/24/2023SESK |
| K221779 | ASEPT Peritoneal Drainage SystemPNG · Traditional | Pfm Medical, Inc. | 05/02/2023SESK |
| K212675 | Aspira Peritoneal Drainage SystemPNG · Special | Merit Medical Systems, Inc. | 12/14/2021SESK |
| K201155 | PleurX Peritoneal Catheter SystemPNG · Traditional | Care Fusion | 10/21/2020SESK |
| K162457 | Rocket Indwelling Peritoneal Catheter (IPC) Insertion KitPNG · Traditional | Rocket Medical Plc | 11/14/2016SEKD |
| K160437 | PleurX Peritoneal Catheter SystemPNG · Traditional | Care Fusion | 11/03/2016SEKD |
| K152105 | Rocket IPC Insertion Set, Rocket IPC Mini Insertion SetPNG · Traditional | Rocket Medical Plc | 03/29/2016SESK |
| K122422 | Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx Slide Valved Peelable…PNG · Traditional | Care Fusion | 10/24/2012SESK |
| K113854 | Pleurx Peritoneal Catheter SystemPNG · Traditional | Care Fusion | 03/19/2012SESK |
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Questions and answers
When was 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 Drain cleared by the FDA?
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 Drain (K241946) received a 510(k) decision of Substantially Equivalent on December 6, 2024, 156 days after the submission was received.
What is the product code of K241946?
The FDA product code is PNG – Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling, a Class II (moderate risk) device regulated under 21 CFR 876.5630.