K962814 is an FDA 510(k) clearance for the DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER. 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 April 14, 1997, 269 days after receiving the submission on July 19, 1996.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5955.
| 510(k) Number | K962814 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 19, 1996 |
| Decision Date | April 14, 1997 |
| Days to Decision | 269 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 |