K011020 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 Biomedicals, Inc. (Louisville, US). The FDA issued a Cleared decision on June 1, 2001, 58 days after receiving the submission on April 4, 2001.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5955.
| 510(k) Number | K011020 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 04, 2001 |
| Decision Date | June 01, 2001 |
| Days to Decision | 58 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 |