K241581 is an FDA 510(k) clearance for the Hemodialysis Catheter. This device is classified as a Catheter, Hemodialysis, Implanted (Class II - Special Controls, product code MSD).
Submitted by Haolang Medical USA Corporation (Bellevue, US). The FDA issued a Cleared decision on May 16, 2025, 347 days after receiving the submission on June 3, 2024.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K241581 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | June 03, 2024 |
| Decision Date | May 16, 2025 |
| Days to Decision | 347 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | MSD - Catheter, Hemodialysis, Implanted |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5540 |