K221779 is an FDA 510(k) clearance for the ASEPT Peritoneal Drainage System. This device is classified as a Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling (Class II - Special Controls, product code PNG).
Submitted by Pfm Medical, Inc. (Carlsbad, US). The FDA issued a Cleared decision on May 2, 2023, 315 days after receiving the submission on June 21, 2022.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5630. For Drainage Of Refractory Ascites With Long-term Occurrence From The Peritoneal Cavity..
| 510(k) Number | K221779 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | June 21, 2022 |
| Decision Date | May 02, 2023 |
| Days to Decision | 315 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | PNG — Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5630 |
| Definition | For Drainage Of Refractory Ascites With Long-term Occurrence From The Peritoneal Cavity. |