K880401 is an FDA 510(k) clearance for the DENVER PERITONEO-VENOUS SHUNT. This device is classified as a Shunt, Peritoneal (Class II - Special Controls, product code KPM).
Submitted by Codman & Shurtleff, Inc. (Randolph, US). The FDA issued a Cleared decision on May 31, 1988, 123 days after receiving the submission on January 29, 1988.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5955.
| 510(k) Number | K880401 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 29, 1988 |
| Decision Date | May 31, 1988 |
| Days to Decision | 123 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | - |
| Product Code | KPM - Shunt, Peritoneal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5955 |