K171618 is an FDA 510(k) clearance for the Symetrex Long Term Hemodialysis Catheter. This device is classified as a Catheter, Hemodialysis, Implanted (Class II - Special Controls, product code MSD).
Submitted by Medcomp (Dba Medical Components, Inc.) (Harleysville, US). The FDA issued a Cleared decision on November 16, 2017, 167 days after receiving the submission on June 2, 2017.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K171618 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | June 02, 2017 |
| Decision Date | November 16, 2017 |
| Days to Decision | 167 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 |