K192807 is an FDA 510(k) clearance for the Duo-Flow Side x Side Double Lumen Catheter. This device is classified as a Catheter, Hemodialysis, Non-implanted (Class II - Special Controls, product code MPB).
Submitted by Medical Components, Inc. (dba MedComp) (Harleysville, US). The FDA issued a Cleared decision on April 23, 2020, 205 days after receiving the submission on October 1, 2019.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K192807 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 01, 2019 |
| Decision Date | April 23, 2020 |
| Days to Decision | 205 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 |