K081288 is an FDA 510(k) clearance for the ASPIRA 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 C.R. Bard, Inc. (Salt Lake Ciy,, US). The FDA issued a Cleared decision on July 18, 2008, 72 days after receiving the submission on May 7, 2008.
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 | K081288 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 07, 2008 |
| Decision Date | July 18, 2008 |
| Days to Decision | 72 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. |