K163458 is an FDA 510(k) clearance for the Zenysis Short-Term Dialysis Catheter. This device is classified as a Catheter, Hemodialysis, Non-implanted (Class II - Special Controls, product code MPB).
Submitted by C.R. Bard, Inc. (Salt Lake Ciy,, US). The FDA issued a Cleared decision on April 4, 2017, 116 days after receiving the submission on December 9, 2016.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K163458 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - De Novo Granted (SEKD) |
| Date Received | December 09, 2016 |
| Decision Date | April 04, 2017 |
| Days to Decision | 116 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | MPB — Catheter, Hemodialysis, Non-implanted |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5540 |