K161921 is an FDA 510(k) clearance for the SwiftNINJA 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 November 4, 2016, 114 days after receiving the submission on July 13, 2016.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1210.
| 510(k) Number | K161921 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 13, 2016 |
| Decision Date | November 04, 2016 |
| Days to Decision | 114 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 |