K161504 is an FDA 510(k) clearance for the Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray. This device is classified as a Catheter, Hemodialysis, Non-implanted (Class II - Special Controls, product code MPB).
Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on January 6, 2017, 219 days after receiving the submission on June 1, 2016.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K161504 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - De Novo Granted (SEKD) |
| Date Received | June 01, 2016 |
| Decision Date | January 06, 2017 |
| Days to Decision | 219 days |
| Submission Type | Special |
| 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 |