K082613 is an FDA 510(k) clearance for the MERIT MICROCATHETER. 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 December 30, 2008, 113 days after receiving the submission on September 8, 2008.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1210.
| 510(k) Number | K082613 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 08, 2008 |
| Decision Date | December 30, 2008 |
| Days to Decision | 113 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 |