K003451 is an FDA 510(k) clearance for the DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHUNT, DENVER PAK, DOUBLED-VALVED ASCITES T. This device is classified as a Shunt, Peritoneal (Class II - Special Controls, product code KPM).
Submitted by Denver Biomedicals, Inc. (Golden, US). The FDA issued a Cleared decision on January 2, 2001, 56 days after receiving the submission on November 7, 2000.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5955.
| 510(k) Number | K003451 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 07, 2000 |
| Decision Date | January 02, 2001 |
| Days to Decision | 56 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KPM — Shunt, Peritoneal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5955 |