K973129 is an FDA 510(k) clearance for the DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITS. This device is classified as a Shunt, Peritoneal (Class II - Special Controls, product code KPM).
Submitted by Denver Biomaterials, Inc. (Evergreen, US). The FDA issued a Cleared decision on March 17, 1998, 208 days after receiving the submission on August 21, 1997.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5955.
| 510(k) Number | K973129 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 21, 1997 |
| Decision Date | March 17, 1998 |
| Days to Decision | 208 days |
| Submission Type | Traditional |
| 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 |