K171571 is an FDA 510(k) clearance for the NexSite HD, Hemodialysis Step Tip Catheter (60cm). This device is classified as a Catheter, Hemodialysis, Implanted (Class II - Special Controls, product code MSD).
Submitted by Marvao Medical Devices, Ltd. (Galway, IE). The FDA issued a Cleared decision on November 30, 2017, 184 days after receiving the submission on May 30, 2017.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K171571 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | May 30, 2017 |
| Decision Date | November 30, 2017 |
| Days to Decision | 184 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | MSD - Catheter, Hemodialysis, Implanted |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5540 |