K170405 is an FDA 510(k) clearance for the BD Curve Ascites Shunt. This device is classified as a Shunt, Peritoneal (Class II - Special Controls, product code KPM).
Submitted by Care Fusion (Vernon Hills, US). The FDA issued a Cleared decision on November 2, 2017, 265 days after receiving the submission on February 10, 2017.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5955.
| 510(k) Number | K170405 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | February 10, 2017 |
| Decision Date | November 02, 2017 |
| Days to Decision | 265 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 |