ASEPT Peritoneal Drainage System
FDA 510(k) K221779 · Pfm Medical, Inc.
510(k) numberK221779
Submission
- Device name
- ASEPT Peritoneal Drainage System
- Applicant
- Pfm Medical, Inc.
Carlsbad, CA, US - Received
- June 21, 2022
- Decision date
- May 2, 2023
- Decision
- Unknown (SESK)
- 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 |
| K241946 | PeritX 1L Drainage Kit (90-1010); PeritX 2L Drainage Kit (90-2010); PeritX Peritoneal…PNG · Traditional | Bard Peripheral Vascular, Inc. | 12/06/2024SE |
| K230319 | Passio Pump Drainage SystemPNG · Traditional | Bearpac Medical | 11/24/2023SESK |
| 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 |
More from Care Fusion
| 510(k) | Device | Decision |
|---|---|---|
| K242763 | JetCan® Pro Safety Huber NeedleFPA · Traditional | 05/02/2025SE |
| K241278 | ASEPT® Glide Peritoneal Drainage SystemPNG · Traditional | 01/14/2025SE |
| K213666 | NuCath Wedge Pressure CatheterDQO · Traditional | 10/06/2022SE |
| K201137 | Asept Surgical Face MaskFXX · Abbreviated | 08/19/2020SE |
| K192802 | primeMidline CathetersPND · Special | 10/28/2019SE |
| K173114 | primeMidline CathetersPND · Traditional | 03/07/2018SE |
| K140137 | Safety Biopsy Needle SystemFCG · Traditional | 03/25/2014SE |
| K122402 | LPP (Low Profile Port)LJT · Traditional | 07/16/2013SE |
| K113354 | Veta Peritoneal Dialysis CatheterFJS · Traditional | 03/13/2012SESK |
| K110914 | Triple Lumen PFM PiccLJS · Traditional | 09/21/2011SE |
Questions and answers
When was ASEPT Peritoneal Drainage System cleared by the FDA?
ASEPT Peritoneal Drainage System (K221779) received a 510(k) decision of Unknown on May 2, 2023, 315 days after the submission was received.
What is the product code of K221779?
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.