K200426 is an FDA 510(k) clearance for the Acute Dual Lumen Hemodialysis Catheter. This device is classified as a Catheter, Hemodialysis, Non-implanted (Class II - Special Controls, product code MPB).
Submitted by Health Line International Corporation (Salt Lake City, US). The FDA issued a Cleared decision on December 24, 2020, 307 days after receiving the submission on February 21, 2020.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K200426 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | February 21, 2020 |
| Decision Date | December 24, 2020 |
| Days to Decision | 307 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 |