K913728 is an FDA 510(k) clearance for the DENVER(R) PERITONEO-SUBCLAVIAN SHUNT. This device is classified as a Shunt, Peritoneal (Class II - Special Controls, product code KPM).
Submitted by Denver Biomedicals, Inc. (Evergreen, US). The FDA issued a Cleared decision on February 18, 1994, 913 days after receiving the submission on August 20, 1991.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5955.
| 510(k) Number | K913728 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 20, 1991 |
| Decision Date | February 18, 1994 |
| Days to Decision | 913 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | KPM — Shunt, Peritoneal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5955 |