K093796 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. (Oceanside, US). The FDA issued a Cleared decision on February 26, 2010, 77 days after receiving the submission on December 11, 2009.
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 | K093796 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | December 11, 2009 |
| Decision Date | February 26, 2010 |
| Days to Decision | 77 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. |