K193082 is an FDA 510(k) clearance for the Fountain ValveTip Infusion Catheter. This device is classified as a Catheter, Continuous Flush (Class II - Special Controls, product code KRA).
Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on August 7, 2020, 276 days after receiving the submission on November 5, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1210.
| 510(k) Number | K193082 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 05, 2019 |
| Decision Date | August 07, 2020 |
| Days to Decision | 276 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | KRA — Catheter, Continuous Flush |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1210 |